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<title><![CDATA[Hays Pharma Drug Safety & Pharmacovigilance Jobs]]></title>
<link>http://www.hayspharma.com/</link>
<description><![CDATA[Hays Pharma Jobs in Drug Safety & Pharmacovigilance category]]></description>
<lastBuildDate>Fri, 06 Aug 2010 14:16:39 GMT</lastBuildDate>
<language>en-gb</language>
<item>
<guid>http://www.hayspharma.com/jobs/england-buckinghamshire/drug-safety-pharmacovigilance/psur-medical-writer/HQ00014211</guid>
<pubDate>Thu, 05 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[PSUR Medical Writer]]></title>
<link>http://www.hayspharma.com/jobs/england-buckinghamshire/drug-safety-pharmacovigilance/psur-medical-writer/HQ00014211</link>
<description><![CDATA[My client is a leading Global Pharmaceutical Organisation. They currently require a Medical Writer to join them initially for a 6 month contract. Periodic Safety Update Report (PSUR) writing experience would be an advantage. Hourly rate is competitive - dependant on individual candidate experience

PRINCIPAL RESPONSIBILITIES: 

Ensure timely, quality aggregate reports for assigned products. 95% 

Support PVAR Scientists in the creation/format of Aggregate reports, including Periodic Safety Update Reports (PSURs) and Summary Bridging Reports. 

Data quality review/correction. 5% 

Ability to reprioritize work based on shifting business needs to meet report timelines. Ability to interact with staff at various levels and in various functional areas to address issues found during review and drive timely solutions. Take personal accountability for decisions and delivering results. Evaluate comments from reviewers of draft reports for appropriateness and respond accordingly. Constantly (re)prioritize work to manage projects often requiring multitasking skills. Data cleaning/QC skills. 

Required Skills/Abilities: 

- Quality orientation/attention to detail. 
- Ability to work independently and as part of a team. 
- Accountability and responsibility for delivery of results. 
- Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines. 
- Ability to follow standard operating procedures 
- Excellent verbal and written communication skills (oral, formal, e-mail and teleconference); ability to communicate in a global environment: diplomatic. 
- Microsoft Word competence (tables, basic formatting). 
- Documentum systems familiarity. 
- Global Safety-Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to pharmacovigilance). 
- Windows OS familiarity/maneuverability. 
- MS Excel skills. 
- Web-based program/Internet competence.

Candidates are expected: to write reports to health authorities, have prior experience in PSUR writing, to have experience in Drug Safety/PVG, to be able to work to deadlines, have great attention to detail, and strong word/excel skills. This role relates to post marked drugs.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
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<guid>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/manager-pharmacovigilance/HQ00015033</guid>
<pubDate>Thu, 05 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Manager Pharmacovigilance]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/manager-pharmacovigilance/HQ00015033</link>
<description><![CDATA[Mein Klient ist ein international führendes, erfolgreiches Pharmaunternehmen in den therapeutischen Bereichen Herz-Kreislauf, Schmerz, Psychiatrie, Antiinfektiva, Onkologie, Immunoscience und Stoffwechel. Sind Sie auf der Suche nach einer neuen Herausforderung? Ab Januar 2011 suchen sie Sie als Alleinverantwortliche/n für die Pharmacovigilance Aktivitäten in Baar. Als Manager Pharmacovigilance (m/f) tragen Sie die Gesamtverantwortung für diesen Bereich in der Schweiz und repräsentieren diese Expertenfunktion innerhalb der Niederlassung, des Konzerns und nach aussen. In dieser Position rapportieren Sie an den Medical Director in der Schweiz.

Konkret verfolgen Sie die Änderungen der nationalen Bestimmungen und adaptieren unsere Prozesse entsprechend. Sie erfüllen die durch Gesetze und firmeneigene Vorgaben geforderten Pharmakovigilanzaktivitäten. Sie stehen in Kontakt zur Swissmedic und arbeiten eng mit der globalen Pharmakovigilanz zusammen. Sie stellen sicher, dass die Pharmakovigilanz in alle wesentlichen Prozesse involviert ist, trainieren die Mitarbeiter und pflegen engen Kontakt mit anderen Abteilungen.

Sie können Ihre Kenntnisse aus dem Gesundheitswesen weiter ausbauen und bekommen Einblicke in das Geschehen eines multinationalen Pharmakonzerns. Sie haben eine Ausbildung in Pharmazie oder Naturwissenschaften und verfügen idalerweise über Erfahrung in der Pharmakovigilanz, Registrierung oder klinischer Forschung. Sie zeichnen sich durch eine strukturierte Arbeitsweise aus und sind absolut zuverlässig. Zudem fühlen Sie sich wohl in einem kollegialen Team und sind offen für internationale Prozesse und vernetzte Strukturen. Im Weiteren haben Sie gute Deutsch, Englisch und Französischkenntnisse sowie ein versierter Umgang mit MS-Office-Anwendungen runden Ihr Profil ab.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/manager-pharmacovigilance/HQ00015034</guid>
<pubDate>Thu, 05 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Manager Pharmacovigilance]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/manager-pharmacovigilance/HQ00015034</link>
<description><![CDATA[Mein Klient ist ein international führendes, erfolgreiches Pharmaunternehmen
in den therapeutischen Bereichen Herz-Kreislauf, Schmerz, Psychiatrie, Antiinfektiva, Onkologie, Immunoscience und Stoffwechel.

Ab Januar 2011  wird ein Alleinverantwortliche/n für die Pharmacovigilance Aktivitäten in Baar gesucht. Als

Manager Pharmacovigilance (m/f)

tragen Sie die Gesamtverantwortung für diesen Bereich in der Schweiz und repräsentieren
diese Expertenfunktion innerhalb der Niederlassung, des Konzerns und
nach aussen. In dieser Position rapportieren Sie an den Medical Director in der
Schweiz.
Konkret verfolgen Sie die Änderungen der nationalen Bestimmungen und adaptieren
unsere Prozesse entsprechend. Sie erfüllen die durch Gesetze und firmeneigene
Vorgaben geforderten Pharmakovigilanzaktivitäten. Sie stehen in Kontakt zur Swissmedic
und arbeiten eng mit der globalen Pharmakovigilanz zusammen. Sie stellen
sicher, dass die Pharmakovigilanz in alle wesentlichen Prozesse involviert ist, trainieren
die Mitarbeiter und pflegen engen Kontakt mit anderen Abteilungen.
Sie können Ihre Kenntnisse aus dem Gesundheitswesen weiter ausbauen und bekommen
Einblicke in das Geschehen eines multinationalen Pharmakonzerns.
Sie haben eine Ausbildung in Pharmazie oder Naturwissenschaften und verfügen
idalerweise über Erfahrung in der Pharmakovigilanz, Registrierung oder klinischer
Forschung. Sie zeichnen sich durch eine strukturierte Arbeitsweise aus und sind absolut
zuverlässig. Zudem fühlen Sie sich wohl in einem kollegialen Team und sind
offen für internationale Prozesse und vernetzte Strukturen. Im Weiteren haben Sie
gute Deutsch- / Englisch- und Französischkenntnisse sowie ein versierter Umgang
mit MS-Office-Anwendungen runden Ihr Profil ab.

Fühlen Sie sich angesprochen? Dann freue ich mich auf ein Gespräch mit Ihnen.
Dirk Pschichholz]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/netherlands/drug-safety-pharmacovigilance/global-safety-team-leader/HQ00015304</guid>
<pubDate>Wed, 04 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Global Safety Team Leader]]></title>
<link>http://www.hayspharma.com/jobs/netherlands/drug-safety-pharmacovigilance/global-safety-team-leader/HQ00015304</link>
<description><![CDATA[An opportunity has arisen for a Global Pharmacovigilance Leader to work in a unique role within a very successful biotechnology company.  Our client requires you to provide your expertise in pharmacovigilance across the disciplines between Safety and Risk Management.  

This pivotal role requires you to lead and motivate a team of safety advisors, responsible for adverse events are reported to the Global Safety Groups and expedited to the regulatory authorities and apply your knowledge to a variety of different element within pharmacovigilance and Risk Management.  

You will be leading and developing the Pharmacovigilance team of Safety Specialists supporting the local business and Global Safety Group, responsible for evaluation of ICSRs, spontaneous/periodic reporting of adverse events, as per local requirements, coordination/generation and submission of Periodic Safety Update Reports (PSURs) and train Pharmacovigilance personnel.  

Ensuring regional fulfils legal and regulatory obligations within pharmacovigilance activities including internal and external customers.

Assist with the development of strategy, policy and processes for the team.  Implement and monitor the effectiveness of operating policies and procedures and facilitate continuous improvement of working practices to ensure optimal efficiency, you will contribute to setting the strategic direction of Pharmacovigilance, and leading change to enhance the effectiveness of  Drug Safety Globally and working as part of Europe. 

With a degree in pharmacy, pharmacology or relevant life science qualification, you will have significant knowledge of working with UK Pharmacovigilance Regulations, ability to negotiate and influence others and the ability of training and coaching other people.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/drug-safety-physician/HQ00014518</guid>
<pubDate>Mon, 02 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Drug Safety Physician]]></title>
<link>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/drug-safety-physician/HQ00014518</link>
<description><![CDATA[Are you a Drug Safety Physician looking for a new opportunity with one of the leading pharmaceutical company&#039;s? My client has a rich pipeline of products in development and focus on delivering innovative products worldwide.

They currently have a position for a Drug Safety Physician who will be responsible for the collection, processing, assessment and reporting of adverse events, with responsibility for post marketing and clinical trial safety reports, the team will form the foundation of medical assessment and evaluation of the safety profile of their products.  The team have primary responsibility for the medical evaluation of define global adverse event reports, including all serious and expedited reports, this role provides guidance and direct participation in the follow-up determination for adverse events, as medically required. They will also participate in review of selected aggregate reports in conjunction with surveillance function of the pharmacovigilance organisation with respect to accuracy, content and signal detection. 

You will be a fully GMC registered physician with broad clinical and drug safety knowledge in post marketing and clinical safety. You will also have demonstrated ability to work in a matrix organisation with a sound knowledge of general medicine and clinical practice. A familiarity with industry principles of drug development, pharmacology, bio statistics, clinical trial methodology and pharmacoepidemiology is preferred.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-middlesex/drug-safety-pharmacovigilance/pharmacovigilance-scientist/HQ00015274</guid>
<pubDate>Mon, 02 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Scientist]]></title>
<link>http://www.hayspharma.com/jobs/england-middlesex/drug-safety-pharmacovigilance/pharmacovigilance-scientist/HQ00015274</link>
<description><![CDATA[My client is a global BioPharma company firmly focused on its mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.  Currently they are looking for a Pharmacovigilance Scientist to join their team.

Within this role you will provide safety information to customers that encourage the safe and effective use of the company&#039;s medicines and positively influence patient treatment decisions, to work in accordance with company SOPS to ensure compliance with legal and regulatory obligations for safety issues and to provide proactive safety support to the business and work with the Pharmacovigilance Manager in developing the company&#039;s UK safety function. 	

The successful candidate will ideally have a Life Sciences degree with previous experience in pharmacovigilance or a medical information service within the pharmaceutical industry, providing a customer focused service with a high level of verbal and written communication. 
Desired experiences include the retrieval and analysis of scientific information, the ability to organise and plan work with little supervision and good time management skills. 
Desired knowledge would include an in depth knowledge of the clinical use and pharmaceutical aspects of medicines, an understanding of pharmacovigilance legislation within the UK, Europe and the ABPI code of practice, a good working knowledge of computer systems and expertise in searching databases to retrieve relevant safety data.
Candidates need to be eligible to work in the UK]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/canada-mississauga/drug-safety-pharmacovigilance/safety-assurance-analyst-nutrition-company/HQ00015270</guid>
<pubDate>Sun, 01 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Safety Assurance Analyst - Nutrition Company]]></title>
<link>http://www.hayspharma.com/jobs/canada-mississauga/drug-safety-pharmacovigilance/safety-assurance-analyst-nutrition-company/HQ00015270</link>
<description><![CDATA[Safety Assurance Analyst required for a 3 month contract at a nutrition company in Mississauga, Ontario.

This junior pharmacovigilance job falls within our client&#039;s Quality Assurance team and requires the candidate to have good experience of PVG, Case Reporting, Serious Adverse Event Reports and Post Marketing Surveillance Activities.

In this role you will be responsible for following standard operating procedures related to Safety Assurance, preparing and reviewing all Adverse Event files and submitting these files to regulatory authorities. Additionally you will be requested to provide support to the Quality Assurance team sporadically.

To apply, you must have a degree in a science based program that can be directly applied to the food, pharmaceutical or nutraceutical manufacturing arena. You must have over two years safety assurance/pharmacovigilance experience and have a process orientated thinking approach with good organizational skills.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/france-paris/drug-safety-pharmacovigilance/charg/HQ00015275</guid>
<pubDate>Sun, 01 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Chargé de Pharmacovigilance (H/F)]]></title>
<link>http://www.hayspharma.com/jobs/france-paris/drug-safety-pharmacovigilance/charg/HQ00015275</link>
<description><![CDATA[Rattaché au QPPV Europe et au sein d&#039;une équipe 5 personnes, vous aurez en charge la gestion des cas de pharmacovigilance pour les produits en développement et pour les produits commercialisés  sur l&#039;Europe, la Suisse, le Moyen-Orient  et l&#039;Afrique (CH-EMEA), selon la politique interne du groupe, les réglementations nationales et européennes.
Vous participerez également aux activités globales de pharmacovigilance du groupe.

Vos missions 
-	Contrôler les entrées et suivi des cas de pharmacovigilance dans la base de données 
-	Participer au Contrôle Qualité afin de faciliter le processus d&#039;évaluation médical
-	Préparer et envoyer les rapports électroniques auprès des  Autorités Compétentes nationales
-	Gérer et recouper les informations de l&#039;ICSR avec celles des différentes des pays
-	Gérer les relations avec les prestataires en terme de pharmacovigilance
-	Implémenter et suivre les E2B, en relation avec les Autorités de Santé locales
-	Participer au développement de la BDD de pharmacovigilance, au niveau global
-	Participer à la préparation des rapports périodiques de sécurité (PSURs et ASRs) ainsi que les rapports de mise à jour 
-	Participer à la veille réglementaire en pharmacovigilance et détection du signal
-	Participer au développement des process/procédures internes en travaillant sur les pratiques ; s&#039;assurer de l&#039;uniformité et du respect des délais des rapports d&#039;événements indésirables
-	S&#039;assurer de la conformité réglementaire au niveau légal et par rapport aux procédures interne au groupe.
Pharmacien ou titulaire d&#039;un diplôme scientifique supérieur, vous avez une expérience de 3 ans minimum en pharmacovigilance en industrie pharmaceutique.
Au-delà de vos compétences médicales vous êtes orienté(e) qualité et prêtez une attention particulière au respect délais et des procédures en vigueur.
Vous savez prendre des initiatives, travailler en autonomie, tout en ayant en excellent relationnel.
Vous savez travailler en transversal, dans un environnement multiculturel et international.
Vous savez interpréter et analyser les documents scientifiques.
Vous maîtrisez les réglementations européennes en matière de pharmacovigilance.
Vous maîtrisez parfaitement l&#039;anglais tant à l&#039;écrit qu&#039;oral (TOEIC = 850) ainsi que les bases de données de pharmacovigilance.
Très polyvalent, vous savez gérer plusieurs projets en même temps tout en gérant les urgences.
Vous êtes rigoureux et organisé et appréciez de travailler dans un environnement international.
Ce poste est un CDI à pourvoir dès que possible.
Si ce poste correspond à votre profil, merci de transmettre votre CV ainsi qu&#039;une lettre de motivation sous format word, accompagnés de vos prétentions salariales et vos disponibilités à l&#039;adresse suivante  claire.dreuillet@hayspharma.com]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/england-buckinghamshire/drug-safety-pharmacovigilance/medical-advisor-assistant-qppv/HQ00015276</guid>
<pubDate>Sun, 01 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Medical Advisor-Assistant QPPV]]></title>
<link>http://www.hayspharma.com/jobs/england-buckinghamshire/drug-safety-pharmacovigilance/medical-advisor-assistant-qppv/HQ00015276</link>
<description><![CDATA[My client is a Global Pharmaceutical who is making a difference to the lives of millions is looking for a Pharmacovigilance Physician to work along side the QPPV. In areas of potential health crisis they have an established portfolio of products and promising pipelines in therapeutic areas such as Oncology, Antiviral, Cardiovascular & Neurology. 


You will lead and support the drug safety systems and compliance, plan, co-ordinate and deliver on processes for the safety group.  In addition, you will provide strategic direction for global pharmacovigilance for the company and oversee all proposed changes form the regulatory authorise and supporting the QPPV.

You will be a trained physician with GMC registration and a broad clinical and drug safety knowledge in post marketing and clinical safety. You will also have demonstrated ability to work in a matrix organisation with a sound knowledge of general medicine and clinical practice, global Pharmacovigilance reports, confident in communication clearly with health and industry professionals of all levels, enthusiastic to learn about and understand the drug development process and drug safety regulatory obligations, the company products and good time management and attention to detail. 

For full details please call Anna 020 922 7141]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/pharmacovigilance-associate/PHJB10</guid>
<pubDate>Sun, 01 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Associate]]></title>
<link>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/pharmacovigilance-associate/PHJB10</link>
<description><![CDATA[Pharmacovigilance Associate - A global healthcare company with expertise in medical devices, pharmaceuticals and biotechnology. The company had global sales of over $10 billion last year and has over 30,000 employees.
Opportunity
You will join a small team reporting to the Drug Safety Manager and will assist in processing adverse event reports from clinical and post marketing studies. You will be responsible for the preparation and submission of reports to the regulatory authorities and to obtain follow up on information for clinical study cases and from non-clinical reports. The company will provide extensive training.
Requirements
 You will have:
 *&nbsp; Some Pharmaceutical Industry experience ideally within Research and Development.
 * A science degree.
 *&nbsp; High motivation and strong communication skills.
 * Conversational English.
 You are preferred to have:
 *&nbsp; A pharmacist痴 license.
 Benefits
 *&nbsp; Office located in Central Tokyo.
 *&nbsp; Opportunity for further education and training.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/pv-physician/JBA</guid>
<pubDate>Sun, 01 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[PV Physician]]></title>
<link>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/pv-physician/JBA</link>
<description><![CDATA[Our client a major pharma with extremely well known brand is currently looking for a safety physician.
Objectives (Purpose of the job)
The safety Physician (SP) will be involved in safety of assigned products from the time of Product sanction to end of lifecycle. The SP may also function as a consultant to early (pre-product sanction) drug development clinical teams. Specific areas of focus will vary depending on the lifecycle stage of the assigned product(s). The SP responsibilities will be carried out in close partnership with multifunctional teams.
Job Responsibilities/Scope of the Position
Responsible for medical case review, including narrative event summary, AE coding, seriousness, expectancy assessments, causality assessments.
Coach PV staff to initiate appropriate follow-up and update essential medical information on ADE reports (depending on the circumstances, direct communication (
±site visits) with the reporter(s) to clarify adverse event(s), and to obtain further medical information as necessary)
Accountable for outcome of Review Meeting of Safety Assessment (case management sub-meeting and surveillance sub-meeting)
Serve as a leader of development team of Safety Risk Mnagement Plan (SRMP), and develop SRMP
Participate in GPS global scientific meetings.
Accountable for the medical safety contents of PMS studies and PSR.
Participate in assessment of safety signals in local clinical trials.
Work as a member of GPS-CRP including Due Diligence activities, cooperate with worldwide GPS-CRP and Japan PT-CRP
Review local regulatory responses on safety issues and participate in meeting with regulators.
Knowledge and Skills Desirable to Perform Role
appropriate assessment skill/competencies for Safety reports based on medical common sense as well as his/her clinical experience
broad knowledge of Safety regulation of both MHLW and ICH/international
influence and leadership among internal group and with external customers including physicians and regulators
communication /interpersonal skill and coaching/mentoring skill
English communication skill
high level of effort and commitment
Qualifications: Education and Work Experience Desirable to Perform Role
degreed Medial Doctor
experienced in the clinical care of patients (preferably 5 years clinical experience, preferably some years experience in internal medicine) ]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-hertfordshire/drug-safety-pharmacovigilance/drug-safety-specialist/HQ00014957</guid>
<pubDate>Fri, 30 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Drug Safety Specialist]]></title>
<link>http://www.hayspharma.com/jobs/england-hertfordshire/drug-safety-pharmacovigilance/drug-safety-specialist/HQ00014957</link>
<description><![CDATA[My client has a strong product pipeline working at the leading edge of the pharmaceutical.  The Drug Safety department works as part of a global function and as part of the team you would be responsible for the project management and preparation of vital drug safety regulatory reports for their innovative products that are underway or recently launched.   

Therefore with a global focus it will be a highly challenging role where you will work closely with various departments in the preparation of Periodic Reports (PSURs) ensuring that these reports comply with company documentation standards and global and local SOPs. You will specifically be responsible for the preparation of EU Annual Safety reports and PSURs and as a new member of this team you will make a major contribution in establishing the role of the team and defining its processes. 

With a Phd, MSc or equivalent in a biomedical discipline or qualifications in pharmacy, nursing or relevant life science qualification and with a sound scientific and medical understanding and the ability to develop your knowledge in different disease and therapeutic areas.

This role requires a good team player as you will take responsibility for your own projects within a supportive and close-knit team.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
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<guid>http://www.hayspharma.com/jobs/england-middlesex/drug-safety-pharmacovigilance/customer-care-advisor/HQ00014958</guid>
<pubDate>Fri, 30 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Customer Care Advisor]]></title>
<link>http://www.hayspharma.com/jobs/england-middlesex/drug-safety-pharmacovigilance/customer-care-advisor/HQ00014958</link>
<description><![CDATA[My client is a top Pharmaceutical company and they are looking for an experienced Customer Care Advisor.

With this role you will be the inbound 1st line general customer support line for all products and services. 

You will be an established customer service individual either from a call centre or other customer service based role. Contact will be via phone, email & letter so strong written and verbal skills are required. 
Your role will be to gain a strong yet general understanding of all products and services to ensure you can handle as many of the calls as possible before escalating to the relevant specialist team. 
You will be working closely with the vaccines team so a medical understanding would be ideal, but not essential. 

Ideally you will have the flexibility to work shifts - Mon to Fri between the hours of 8am - 6pm. 
Shifts are rotated amongst the team week by week and are as follows: 
8-4:30pm 
8:45-5:15pm 
9:30-6pm]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/director-of-risk-managementepidemiology-new-team/HQ00014982</guid>
<pubDate>Fri, 30 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Director of Risk Management/Epidemiology - New Team]]></title>
<link>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/director-of-risk-managementepidemiology-new-team/HQ00014982</link>
<description><![CDATA[Director of Risk Management/Epidemiology required for a thriving pharmaceutical firm which is currently building a brand new Epidemiology and Risk Management team based across the US.

These roles are based in Florida, North Carolina or San Francisco, although there will be some flexibility on this.

This position will oversee all aspects of safety and risk management throughout the development process so you will need top possess strong leadership and communication skills to ensure product development teams across multiple sites work together from Phase 1 to commercialization.

The candidate should demonstrate the ability to communicate safety principles and the meaning of pertinent data to both the scientific and non-scientific communities.

In this business critical position you will be expected to

- play a leading role in the development, implementation and management of comprehensive risk management systems, both internally and externally, for risk detection, risk assessment and risk minimization for investigational and marketed products which will balance benefit and risk for the client company.
- identify safety and risk management issues from clinical trial data and determine a proper course of action subsequently.
- oversee the development of risk management plans for company products with responsibility for generating epidemiology information on the natural history of disease, risk factors and drug utilization in targeted populations.
- design and conduct pharmacoepidemiology studies, namely observational post-marketing safety studies as well as analyze and interpret Serious Adverse Event Reports for validity and accuracy
- develop methodologies for establishing thresholds for product safety signals and to contribute to data mining activities.
- contribute to Pharmacovigilance Plans in NDAs/BLAs.
- manage activities related to the functioning of corporate safety committees such as background reports/materials.
- assist in the creation of SOPs, work practice and guidelines, forms and templates, and other communications related to risk management, epidemiology and Patient Safety. 

This role will require you to work with other team leaders in product development departments to ensure the product development process proceeds in a timely, safe and efficient manner.

For this role you must be Pharm.D or PhD educated (strong Masters candidates will be considered) with an ability to think strategically, particularly in regard to Risk Management planning. You will need strong research skills and a track record in scientific communications and publishing.

You should have 3-5 years of experience with drug development experience in either the pharmaceutical industry and the right candidate must also demonstrate strong leadership and communication skills to be able to facilitate the implementation of risk management and safety guidelines in all facets of development while collaborating with other team leaders.

Ideally you will be proficient with statistical software packages (e.g., SAS) and must be able to query databases for preparation of data analyses. Knowledge of FDA, ICH, CIOMS and GCP guidelines preferred.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/sweden/drug-safety-pharmacovigilance/director-of-the-uppsala-monitoring-centre/006006</guid>
<pubDate>Thu, 29 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Director of The Uppsala Monitoring Centre]]></title>
<link>http://www.hayspharma.com/jobs/sweden/drug-safety-pharmacovigilance/director-of-the-uppsala-monitoring-centre/006006</link>
<description><![CDATA[ Director of The Uppsala Monitoring Centre
 This is a unique opportunity to make a difference to the safety of medicines on an international level, at a time when the challenges of delivering safe healthcare globally have never been more in the public eye.
 The Uppsala Monitoring Centre is the field name of the WHO Collaborating Centre for International Drug Monitoring located in Sweden. An independent organisation of scientific excellence in the area of medicines safety. The Centre offers a range of products and services related to the WHO database of reports of Adverse Drug Reactions from health care providers and patients in member countries of the WHO Programme.
 The UMC provides essential services to regulatory agencies, the pharmaceutical industry, academia and health professionals. Being economically independent and self financing the UMC’s Director is responsible for the operational management of the Centre including business and financial development. 
 Do you have the public health commitment, scientific excellence, management acumen, people skills, creativity, drive and energy to lead the way?
 The role - As Director you will:
  - Act as the authoritative medical expert of pharmacovigilance and leader of the UMC operations
  - Keep the UMC at on the cutting edge of medicines safety issues
  - Liaise with the World Health Organization and national pharmcovigilance centres
  - Collect and communicate information from member countries about the benefits, harm and risks of medicines
  - Lead a dedicated multidisciplinary team of 60 people at the UMC
  - Travel all over the world
 Qualifications
  - Medical degree and PhD, or equivalent, in relevant areas of science
  - Extensive experience of pharmacovigilance
  - People-management and&nbsp; leadership skills
  - Experience from a strategic role
  - Experience in business development and financial management 
  - Excellent&nbsp; communication and negotiation skills (Fluency in English required, proficiency in other languages also preferred)
 Personal profile - You are:
  - Hardworking, self-driven and proactive
  - Experienced and well respected leader
  - An excellent relationship builder
  - Passionate and enjoy working in an international environment
 If you think this could be you, visit our website www.who-umc.org and read more on www.who.int/medicines/areas/quality_safety/en/index.html
 Application
  In this recruitment UMC is working with Hays.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 
  Please submit your application with your resumé and a personal letter to Stockholm@haysexecutive.com. We are continuously reviewing applications throughout the entire application period and would like your application no later than February 28, 2009. Mark your application “UMC”. If you have questions, please contact Helena Marteus or Marita Ribohn on&nbsp; +46 8-588 043 00.


  &nbsp;]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/pharmacovigilance-officer/HQ00011237</guid>
<pubDate>Wed, 28 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Officer]]></title>
<link>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/pharmacovigilance-officer/HQ00011237</link>
<description><![CDATA[Brand new role for a Pharmacovigilance Officer with 6 months experience. You will join a team of 4 who work across all aspects of Safety. They are a close knit team where you will be encouraged to take the lead on projects and to continually develop within the team.

You will be responsible for the following:
Records and reports all adverse drug reactions relating to company products as per UK/EU requirements whether received from MHRA, Medical Information or literature sources. Prepares Expedited Report cover letters and handles AE follow-up requests. 
Conducts routine weekly literature searches to include detection of adverse events or important safety information relating to company products 
Acts as MHRA portal administrator for receiving and processing ASPRs 
Co-ordinates bi-annual DAP review with requests to the MHRA 
Quarterly tracking of expedited cases from National Competent Authorities (specially MHRA) Compilation of compliance metrics (15 day reporting timeline) and quarterly STADA compliance report 
Diarising PSUR Data Lock Points and submission cycles in order to coordinate the submission of all Periodic Safety Update Reports (PSURs) as per UK/EU requirements Dissemination of adverse event reports to partner/distributor companies; tracking acknowledgements and local submission as required. 
Maintenance of existing pharmacovigilance agreements to include review every two years as tracked in agreements database. 
Company compliance with MHRA/EU pharmacovigilance regulations, directives and guidelines

For a full and comprehensive job description and information on the company please contact Liadan Aylward on + 44 (0)20 7922 7127]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/project-leader-head-of-risk-management/HQ00014952</guid>
<pubDate>Tue, 27 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Project Leader Head of Risk Management]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/project-leader-head-of-risk-management/HQ00014952</link>
<description><![CDATA[My client is looking for a Project Leader, Head of Risk Management Office to support the Global Drug Safety Division. You will be in charge of the overall risk management strategic plan. You will have 6 direct reports (India/US/Switzerland). This position is based in Basel, Switzerland.

Main responsibilities

1. Lead initiatives to develop, implement and manage state-of-the-art processes, methodology and tools to support the development, implementation, and compliance with global risk management plans, including the RMP website. 
2. Lead the development and implementation of training programs for global and local relevant line functions within Development and the Company on risk management plan processes, tools, and compliance. 
3. Develop and oversee SOPs, KPIs, quality standards and associated monitoring tools to ensure compliance and quality management of global risk management plans. 
4. Manage a system for tracking and monitoring risk management plans and their component objectives and tools to identify areas for improvement and compliance. 
5. Represent the company on assigned external industry projects on risk management methodology and risk management tools. 
6. Work closely with Head MSO to develop, implement, and evaluate the policy regarding risk management plans. 
7. Support innovation of safety risk management through continuous assessment and incorporation of new technology, scientific approaches, and data sources and evaluate their alignment with the strategy. 
8. Contribute senior level expertise to the scientific and operational aspects of Medical Safety Operations. 
9. Liaise with DS&E TA and CPO colleagues to ensure continuous improvement of risk management plan activities through knowledge sharing and integration of learnings. 
10. Collaborate closely with other line functions in Development, the Company, and other sectors to optimize the risk management plan system. 
11. Supervise the RMP Office staff, e.g. RMP Scientist, Document Administrators 
12. Consult with Global and local RMP Managers on issues related to RMP policy and processes.

Education & Experience

- Advanced scientific or medical degree (e.g. MD, PhD, PharmD) required. 
- Languages Fluent in spoken and written English. Understanding of another major language (e.g. French, German, Spanish) desirable. 
- Solid experience in pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs. 
- Demonstrated leadership of projects in a global setting. 
- Excellent teamwork in a multidisciplinary environment. 
- Excellent written and oral communication skills. 
- Strong knowledge of global regulatory safety environment and clinical drug development. 
- Excellent verbal and written communication skills. 
- Innovative critical thinking. Process and performance oriented drive to improve working practice. 
- Prior experience with Risk Management Plans is desirable.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/france-paris/drug-safety-pharmacovigilance/charg/HQ00015229</guid>
<pubDate>Mon, 26 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Chargé de Pharmacovigilance (H/F)]]></title>
<link>http://www.hayspharma.com/jobs/france-paris/drug-safety-pharmacovigilance/charg/HQ00015229</link>
<description><![CDATA[Au sein du département Pharmacovigilance Europe et rattaché au Directeur de la Pharmacovigilance Europe, vous serez responsable de l&#039;analyse des cas de PV recueillis sur les produits en développement et commercialisés.

Vous devrez donc 
rapporter les cas aux autorités de santé et comités d&#039;éthique du pays concerné en respectant les délais
Apporter soutien aux études cliniques  au niveau Européen
Archiver les documents relatifs aux cas de PV, selon les procédures internes
Maintenir à jour les SOPs et sensibiliser le personnel.

Titulaire d&#039;un diplôme de pharmacien ou équivalent (scientifique supérieur), vous avez acquis une expérience de 2 ans minimum en industrie pharmaceutique.
Vous maitrisez les réglementations nationales et internationales relatives à la pharmacovigilance, et justifiez IMPERATIVEMENT d&#039;un bon niveau d&#039;anglais oral et écrit.
Vous êtes pro actif et savez travailler dans l&#039;urgence.
Vous avez un bon relationnel et savez travailler en équipe.

Ce poste est un CDD d&#039;une durée de 6 mois, à pourvoir dès septembre 2010.
Si ce poste correspond à votre profil, merci de transmettre votre CV word, vos prétentions salariales ainsi que vos disponibilités à l&#039;adresse suivante claire.dreuillet@hayspharma.com]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/senior-pharmacovigilance-executive/HQ00014677</guid>
<pubDate>Fri, 23 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Pharmacovigilance Executive]]></title>
<link>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/senior-pharmacovigilance-executive/HQ00014677</link>
<description><![CDATA[With new project, they are developing their Pharmacovigilance Department within the UK and as such have a vacancy for a Senior Pharmacovigilance role.

We are who can make an immediate contribution to the Pharmacovigilance, post-marketing work of the team and who has the potential and commitment to grow with the role and expand their responsibilities.

Personal style and motivation will be as important as qualifications and experience. To fill the position, we need an individual with experience in writing PSURs, preparation of ASR&#039;s triage/ QC and processing, of post marketing and have had involvement reporting to the EMEA and FDA as well as an enthusiastic, motivated individual; tenacious, keen to learn and to develop the team; and prepared to roll up their sleeves and get on with the job. 

This is an outstanding opportunity, offering the chance to help build post-marketing function in a global role and to have real influence in this dynamic, growing business.

As a successful candidate you be responsible for the production of PSUR&#039;s and bridging summaries, prioritise and manage individual workload&#039;s to ensuring regulatory time lines are kept and liase with the Head of PVG and the Pharmacovigilance Manager. A Nursing/Pharmacy/ Life Sciences degree. Oral, written and organisational skills are essential as well as the ability to be flexible and pragmatic.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/seniordirector-pvg-and-risk-management/HQ00014915</guid>
<pubDate>Fri, 23 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior/Director - PVG and Risk Management]]></title>
<link>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/seniordirector-pvg-and-risk-management/HQ00014915</link>
<description><![CDATA[A leading pharmaceutical company who work across specialist medicines are seeking a PVG and Risk Management Director based in their offices in MA.

Role Details:

Under the oversight of the Medical Surveillance and Risk Management Vice President and in collaboration with key colleagues in PV&RM, the PV&RM Director is responsible for ensuring appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for assigned products, globally.

Requirements:

MD
PVG and risk management experience
Ideally experience in Internal Medicine or Endocrinology
Global experience required, single case review & risk management plan experience required. 
Experience with Clinical and Marketed products required.

FULL VISA and Relocation on offer for European candidates!]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/pharmacovigilance-specialist/017</guid>
<pubDate>Fri, 23 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Specialist]]></title>
<link>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/pharmacovigilance-specialist/017</link>
<description><![CDATA[A global healthcare company with expertise in medical devices, pharmaceuticals and biotechnology. The company is involved in the development of critical therapies to treat chronic diseases such as hemophilia, immune deficiencies and other blood disorders and also provides a range of support services for these patients. The company manufactures specialty pharmaceuticals and devices that help physicians, pharmacists and nurses deliver critical fluids and drugs. The company had global sales of over $10 billion last year and has over 30,000 employees.
Opportunity
You will join a small team reporting to the Drug Safety Manager and will assist in processing adverse event reports from clinical and post marketing studies. You will be responsible for the preparation and submission of reports to the regulatory authorities and to obtain follow up on information for clinical study cases and from non-clinical reports. The company will provide extensive training.
Requirements
You will have:
  * Over 2 years of Pharmaceutical Industry experience ideally within Research and Development.
  * A science degree (life science or related is preferred) .
  * High motivation and strong communication skills.
  * Fluent Japanese.
  * Conversational English.
  You are preferred to have:
  * A pharmacist’s license.
Benefits
* &nbsp;Office located in Central Tokyo.
  * &nbsp;Established training program.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/china/drug-safety-pharmacovigilance/pharmacovigilance-manager/00009111</guid>
<pubDate>Wed, 21 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Manager]]></title>
<link>http://www.hayspharma.com/jobs/china/drug-safety-pharmacovigilance/pharmacovigilance-manager/00009111</link>
<description><![CDATA[Pharmacovigilance ManagerLocation: Beijing, China
Report line: Medical Director
Company Profile
This is an innovative and customer-cared pharma company whose philosophy is to be the world leading supplier to the healthcare industry.&nbsp; They have operation offices throughout the world with over 40,000 employees.
They offer a wide range of medical products: anesthesia, intensive care, cardiology and surgery-related stuff.&nbsp; Moreover, they have different business units to focus on different products/clients to make them professional and to be specialist/expert on its industries.
Job Summary
- Handle the individual AEs and other pharmacovigilance data/report properly
- Manage periodic review reports and product safety alert
Responsibilities:
- Monitor local pharmacovigilance regulations
- Establish appropriate interfaces with regulatory affairs, marketing and sales, quality assurance.
- Maintain tracking systems to monitor compliance to local regulatory requirements and global SOPs
- Perform or ensure medical review
- Coordinate and manage local PV alert in collaboration with corporate and local management.
- Solve medical marketing issue where necessary
Requirements:
- Master degree is desirable
- Excellent communication skills both in English and Chinese
- Around 2-3 years pharmacovigilance experience is necessary
- Practical experience as hospital doctor is advantageous
Apply now! Please contact Tom Tan on 86-21-23229600*2326 or email him via tom.tan@hays.cn.&nbsp; 

 &nbsp;]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/drug-safety-advisor/HQ00015159</guid>
<pubDate>Tue, 20 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Drug Safety Advisor]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/drug-safety-pharmacovigilance/drug-safety-advisor/HQ00015159</link>
<description><![CDATA[My client is looking for a Drug Safety Advisor. My client is a world leading pharmaceutical company specialised in anaemia products and the development of medicines for the treatment of renal related autoimmune diseases (development, manufacture and marketing) . Their consumer healthcare business manufactures both internally developed and in-licensed products, which they market internationally. 
 
This is a permanent position based near Zurich, Switzerland.
 
AREA OF RESPONSABILITY

* Coordinate processing of post-authorization safety data received from worldwide sources (spontaneous, literature and others)
* Ensure appropriate tracking of inbound and outbound communication related to individual safety cases
* Coordinate work of in-contracted and outsourced resources for case processing activities
* Ensure consistency in case classification, causality, labeling, MedDRA, WHO-Drug coding and narratives
* Liaise with Other Drug Safety Advisors regarding their case processing tasks (medical evaluation, QC)
* Liaise with Consultants and Service Providers in post-marketing surveillance
* Manage the reporting matrix of post-authorization individual safety cases towards EU and non-EU Health Authorities and Contractual Partners; ensure compliant expedited reporting (time, channel, format)
* Coordinate case follow-up activities and reconciliation with Health Authorities / Contractual Partners
* Coordinate worldwide literature screening; ensure appropriateness of documentation; screen results for case inclusion and safety relevance
* Liaise with affiliates and partners for local literature, expedited compliance
* Liaise with the Drug Safety IT Specialist in all aspects of E2B reporting; database and application management; data retrieval; custom reporting
* Measure and present internal and regulatory compliance
* Ensure timely and appropriate post-authorization data presentation for PSURs, other aggregate reports, benefit-risk assessment, signal detection and risk management activities
* Liaise with Other Drug Safety Advisors in Clinical and Medical Safety regarding safety issue workups and risk assessment
* Update and maintain procedural documentation in post-marketing surveillance processes and ensure compliance; Track and manage CAPAs in post-marketing surveillance processes
* Provide input to Safety Data Exchange Agreements and Pharmacovigilance System Description documents regarding the post-marketing surveillance processes
* Conduct safety trainings for new Pharmacovigilance staff and other company units
* Liaise with Quality Assurance in handling Product Technical Complaints associated with adverse events or received initially by Drug Safety
* Assists in replying to medical and scientific inquiries
 
YOUR PROFILE 

* University degree in pharmacology / medicine / other life sciences
-*Working experience in post marketing surveillance / drug safety operations including case classification, causality, labelling, MedDRA, WHO-Drug coding and narratives
* Good understanding of aggregate reporting; benefit-risk assessment; signal detection and risk management
* Fluency in English
* Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
* Experience with drug safety databases (especially ARISg)]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-kent/drug-safety-pharmacovigilance/pharmacovigilance-associate/HQ00015164</guid>
<pubDate>Tue, 20 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Associate]]></title>
<link>http://www.hayspharma.com/jobs/england-kent/drug-safety-pharmacovigilance/pharmacovigilance-associate/HQ00015164</link>
<description><![CDATA[An opportunity has arisen for a Pharmacovigilance Associate within one of the leading Pharmaceuticals Companies.

This role is to provide day to day pharmacovigilance support for the in-line veterinary products.

As the ideal candidate you will have previous experience within Drug Safety e.g. case triage, case data entry, case reporting.

Please call Roberta Atkins on 020 7922 7131 or email Roberta.atkins@hayspharma.com for further information.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-surrey/drug-safety-pharmacovigilance/drug-safety-officer/HQ00015165</guid>
<pubDate>Tue, 20 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Drug Safety Officer]]></title>
<link>http://www.hayspharma.com/jobs/england-surrey/drug-safety-pharmacovigilance/drug-safety-officer/HQ00015165</link>
<description><![CDATA[An opportunity has arisen for a Drug Safety Officer within one of the leading Pharmaceuticals Companies.

Within this role you will assist in the input and processing of adverse event data generated from spontaneous and clinical trial sources working to agreed procedures under close supervision. You will assist in maintaining the adverse event database and reporting to Regulators.	

As the ideal candidate you will have previous experience within Drug Safety and also using Argus database.

Please call Roberta Atkins on 020 7922 7131 or email Roberta.atkins@hayspharma.com for further information.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/safety-physician/MI51</guid>
<pubDate>Mon, 19 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Safety Physician]]></title>
<link>http://www.hayspharma.com/jobs/japan/drug-safety-pharmacovigilance/safety-physician/MI51</link>
<description><![CDATA[We are looking for a safety physician for our client.&nbsp; The job Responsibilities/Scope of the Position are:
 - Responsible for medical case review, including narrative event summary, AE coding, seriousness, expectancy assessments, causality assessments.
 - Coach PV staff to initiate appropriate follow-up and update essential medical information on ADE reports (depending on the circumstances, direct communication (±site visits) with the reporter(s) to clarify adverse event(s), and to obtain further medical information as necessary)
 - Accountable for outcome of Review Meeting of Safety Assessment (case management sub-meeting and surveillance sub-meeting) 
 - Serve as a leader of development team of Safety Risk Mnagement Plan (SRMP), and develop SRMP 
 - Participate in GPS global scientific meetings. 
   -&nbsp; Attend and present safety signals at SEC
  -&nbsp; Accountable for the medical safety contents of PMS studies and PSR. 
   - Participate in assessment of safety signals in local clinical trials.
  -&nbsp; Work as a member of GPS-CRP including Due Diligence activities, cooperate with worldwide GPS-CRP and Japan PT-CRP  
 -&nbsp; Review local regulatory responses on safety issues and participate in meeting with regulators. 
 -&nbsp; Review medical letters and medical information materials provided to HCP regarding product safety (ex. Explanation brochure for precaution for use, etc.)
  Knowledge and Skills Desirable to Perform Role
  -&nbsp; appropriate assessment skill/competencies for Safety reports based on medical common&nbsp; sense&nbsp; as well as his/her clinical experience 
  -&nbsp; broad knowledge of Safety regulation of both MHLW and ICH/international
  -&nbsp; therapeutic (company products) knowledge
  -&nbsp; influence and leadership among internal group and with external customers including physicians and regulators
  -&nbsp; communication /interpersonal skill and coaching/mentoring skill
  -&nbsp; English communication skill
  -&nbsp; high level of effort and commitment
  Qualifications: Education and Work Experience Desirable to Perform Role
  -&nbsp; degreed Medial Doctor
  -&nbsp; experienced in the clinical care of patients (preferably 10 years clinical experience, preferably some years experience in internal medicine) 
  -&nbsp; clinical or medical coaching/teaching experience ]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-london/drug-safety-pharmacovigilance/senior-drug-safety-specialist/HQ00014156</guid>
<pubDate>Fri, 16 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Drug Safety Specialist]]></title>
<link>http://www.hayspharma.com/jobs/england-london/drug-safety-pharmacovigilance/senior-drug-safety-specialist/HQ00014156</link>
<description><![CDATA[Joining the company as a Senior Drug Safety Associate your main function will be will be responsible for contributing to the monitoring of the safety of the clients products. This will be both during development and after marketing authorisation approval in order to meet international regulatory requirements, development objectives and clinical excellence.   Information management and update of appropriate tracking tools for designated projects, data entry of SAEs, query generation, distribution of individual SAE reports and production of SAE summaries, adherence to SOPs, guidelines and all appropriate regulations. 

This is a pharmacovigilance role where you will work independently, establishing work priorities and direction with minimal input from your manager and mentoring team members.

With a Life Science Degree, nursing or related discipline you will have relevant experience in areas such as auditing, Good Practice of Quality Guidelines and Pharmacovigilance. A superb working knowledge of global pharmacovigilance regulations is required as well as the ability to project manage. 

For further details please call Anna on 0207 922 7141]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/pharmacovigilance-specialist-dallas-tx/HQ00014575</guid>
<pubDate>Fri, 16 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Specialist - Dallas, TX]]></title>
<link>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/pharmacovigilance-specialist-dallas-tx/HQ00014575</link>
<description><![CDATA[Pharmacovigilance Specialist required for a medical device and healthcare giant based in Texas. Our client is currently rapidly expanding their Pharmacovigilance team as they look to develop their trial study capabilities.
This position is within a team-oriented environment and will be responsible for receiving and evaluating adverse drug experience.

Responsibilities include, but are not limited to:
- Receiving and distributing adverse event reports for investigational and marketed products
- Coordinating adverse event report activities with other members of the group
- Submitting reports to regulatory authorities
- Preparing and coordinating of reviews of individual case safety reports
- Supporting Risk Management Plans by serving as a coordinator for the preparation and gathering of data
- Collecting data as part of a Pharmacovigilance plan, Risk Management Plan and surveillance activities
- Supporting surveillance activities regarding vendors, consultants and databases
- Supporting Physicians in case series reviews and data reviews
- Participating in preparation, analysis and writing of regulatory reports and labelling support documents.
- Preparing and reviewing FDA MedWatch, ICH CIOMS forms and other required regulatory reporting forms as well as coding of adverse event terms in MedDRA.

For this role you should have a PharmD or an advanced degree in nursing or a health care related discipline (eg MS or Masters of Public Health). You should have previous experience within the pharmaceutical or health care industry (nurse, pharmacist, physician etc), preferably four years (minimum) in a pharmacovigilance department.
Additionally, you should be able to demonstrate familiarity with industry principles of drug safety, drug development, pharmacology and statistics as well as basic knowledge of common data processing software.
You should also have proven experience in interpreting and presenting scientific and technical data in a written and verbal format. Working knowledge of FDA regulations governing adverse event collection and reporting will benefit your application.

Salary on offer is negotiable depending on experience.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/england-hertfordshire/drug-safety-pharmacovigilance/drug-safety-associate/HQ00014623</guid>
<pubDate>Fri, 16 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Drug Safety Associate]]></title>
<link>http://www.hayspharma.com/jobs/england-hertfordshire/drug-safety-pharmacovigilance/drug-safety-associate/HQ00014623</link>
<description><![CDATA[We have a new opening for a Drug Safety Associate with one of the leading Pharmaceutical Companies. You will join a department who has been developed over the past year. Each team is split by therapeutic area and personality is as important as technical skills as the team are proud of their supportive and family based environment.

The successful candidate will be responsible for the processing and monitoring of adverse event reports for investigational and marketed products in accordance with company SOPs and guidelines, maintaining regulatory compliance. This will include the following activities: evaluation of adverse event reports to confirm regulatory reporting status; processing adverse event reports including preparation of clinical narrative summaries, and coding adverse events, indications for use and concomitant medical conditions; reviewing data entry of peer reports to ensure quality entry and appropriate output for aggregate reports; evaluation of cases for product quality assurance reporting requirements; determining requirement for and requesting case follow-up information.  

It is essential to have the ability to prioritise and organise workflow activities in a team environment and good communication and writing skills demonstrated by the ability to interpret medical information and write summary reports. With experience of single case processing you will have a good knowledge of medical terminology with the ability to provide constructive feedback to team members, good problem solving skills with the ability to adapt to ongoing change. Having a minimum of a Bachelor&#039;s degree in health related field or be a registered nurse or pharmacist,  you will have at least some experience within Pharmacovigilance.
Candidates need to be eligible to work in the UK


Please call Roberta on 0207 922 7131 or email roberta.atkins@hayspharma.com]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/head-of-pharmacovigilance/HQ00014633</guid>
<pubDate>Fri, 16 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Head of Pharmacovigilance]]></title>
<link>http://www.hayspharma.com/jobs/england-berkshire/drug-safety-pharmacovigilance/head-of-pharmacovigilance/HQ00014633</link>
<description><![CDATA[We are looking for an individual with a solid amount of experience with Pharmacovigilance and medically trained to lead, manage and conduct of Pharmacovigilance projects, involving development of medical services and Pharmacovigilance proposals as well as client liaison to ensure business targets are met.

My client is a leading speciality pharmaceutical company and has a broad portfolio of products targeting the US, Canada, Australia and Europe. They have consistently aimed to attract and retain highly skilled and talented people who play an active part in the development of the company by rewarding excellence and recognising individual contributions.

As the Head of Pharmacovigilance, you will demonstrate leadership and manage and investigational and post-marketing regulatory reporting and pharmacovigilance activities for assigned products, prepare and assist the QP ensuring compliance of SOPs and local and European Pharmacovigilance regulations.

You will be responsible for communicating with EU affiliates and ensuring a high standard of working practices between groups, while providing direction to central PVG and European Affiliates.

You will have extensive experience working in Pharmacovigilance systems both clinical and marketed products for a global department, and the ability to manage and lead individuals.  You will also be medically qualified with GMC registration, a proven track record of safety data management and  an aptitude for communicating across all levels.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/england-surrey/drug-safety-pharmacovigilance/senior-pharmacovigilance-officer/HQ00014867</guid>
<pubDate>Fri, 16 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Pharmacovigilance Officer]]></title>
<link>http://www.hayspharma.com/jobs/england-surrey/drug-safety-pharmacovigilance/senior-pharmacovigilance-officer/HQ00014867</link>
<description><![CDATA[My client is one of the top 5 Pharmaceuticals within Europe and Globally. Working across a number of therapeutic areas they are proud of their social development policy and their continued investment into Research & Development both globally and at a local level. As a result of expansion they have a new vacancy for a Senior Pharmacovigilance Officer.

As the successful candidate you will be responsible for information management, case entry, represent the PVG function, become involved in procedures and initiatives to improve process / efficiencies, act as mentor and assist in development and training of those less experienced, develop and manage appropriate tracking tools, provide a pivotal role in PSUR production for company products including the training of junior team members and support the PVG team in the absence of the manager.

With a degree in Life Sciences or a Healthcare discipline you will be a strong communicator with excellent problem solving skills, good PSUR writing and presentation skills with attention to detail.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/switzerland-basel/drug-safety-pharmacovigilance/brand-safety-leader/HQ00011167</guid>
<pubDate>Thu, 15 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Brand Safety Leader]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/drug-safety-pharmacovigilance/brand-safety-leader/HQ00011167</link>
<description><![CDATA[My client is looking for a Brand Safety Leader, based in Switzerland - Basel.

Main responsibilities
***********************	
1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.  
2. Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.  
3. Develops and updates, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. 
4. Leads ICT Safety Subteam. Serves as safety representative on International Clinical Team (and IPT). 
5. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.  
6. Responsible for initial development and updates of safety information in Basic Prescribing Information (core global labeling), including addressing safety issues optimally in all project/product labeling claims.  
7. Responsible for responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Responsible for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion.  
8. Provides integrated safety input into all regulatory documents required during active development  
9. Reviews and provides integrated safety input into clinical study protocols and clinical study reports, including Brand Optimization studies  
10. Co-ordinates involvement of external experts (e.g. authors of &#039;&#039;white papers&#039;&#039;, members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.)  
11. Prepares and may present brand safety issues to internal Boards and other meetings  
12. Provides relevant input for IPT, ICT and TA Expert Panel meetings, as needed  
13. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.  
14. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.  15. Serves as and performs activities of Pharmacovigilance Leader as needed.	

Minimum skills to have
***************************
- Education (minimum/desirable) Medical Degree required. Specialty Board certification desirable. 
- Useful additional degrees Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)  
- Languages Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.   

Experience/Professional requirement
*******************************************  
-  some years clinical experience postdoctoral  
- some years experience in drug development in a major pharmaceutical company (if possible some years in a global position), including some years in safety at an operational or medical position-  
- Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.  
- Experience in leading cross-functional, multi-cultural teams  
- Experience with (safety or others) issue management  
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/england-hertfordshire/drug-safety-pharmacovigilance/pharmacovigilance-operations-physician/HQ00014828</guid>
<pubDate>Tue, 13 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Pharmacovigilance Operations Physician]]></title>
<link>http://www.hayspharma.com/jobs/england-hertfordshire/drug-safety-pharmacovigilance/pharmacovigilance-operations-physician/HQ00014828</link>
<description><![CDATA[I have a position for a Drug Safety Physician Manager who will be responsible for global safety operations providing medical review of Adverse Event reports, case narratives and analysis of similar events. In addition, this role involves providing expertise and to Drug Safety Physicians and Specialists, including assisting with queries relating to the medical interpretation of Adverse Event reports and laboratory data.  

You will be a trained physician with GMC registration of EU equivalent broad clinical and drug safety knowledge in post marketing and clinical safety . You will also have demonstrated ability to work in a matrix organisation with a sound knowledge of general medicine and clinical practice and liaise with Regulatory Affairs and develop relationships with other functions.

You will be confident in communication clearly with health and industry professionals of all levels, enthusiastic to learn about and understand the drug development process and drug safety regulatory obligations, good time management and attention to detail.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/netherlands/drug-safety-pharmacovigilance/senior-medical-director-in-pharmacovigilance/HQ00015082</guid>
<pubDate>Mon, 12 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Medical Director in Pharmacovigilance]]></title>
<link>http://www.hayspharma.com/jobs/netherlands/drug-safety-pharmacovigilance/senior-medical-director-in-pharmacovigilance/HQ00015082</link>
<description><![CDATA[My client currently has an opening for a Senior Medical Director in Pharmacovigilance. Due to the growth within Pharmacovigilance team, this newly created role will be responsible for the European PVG team.  You will lead the planning, co-ordination and delivery of assigned projects, review of the safety products of investigational and marketed products, safety signal detection, PSURs, and ASRs.

 In addition, you will provide strategic direction and be responsible for the Safety group at all levels (PVG Physicians, medical writers and Pharmacovigilance Associates) and oversee the writing of aggregate reports, risk management plans, and supporting the QPPV.
 
You will be a trained physician with broad clinical and drug safety knowledge in post marketing and clinical safety. You will also have demonstrated ability to work in a matrix organisation with a sound knowledge of general medicine and clinical practice, global Pharmacovigilance reports, confident in communication clearly with health and industry professionals of all levels, enthusiastic to learn about and understand the drug development process and drug safety regulatory obligations, the company products and good time management and attention to detail.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/china/drug-safety-pharmacovigilance/clinical-pharmacologist/00009259</guid>
<pubDate>Mon, 12 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Clinical Pharmacologist]]></title>
<link>http://www.hayspharma.com/jobs/china/drug-safety-pharmacovigilance/clinical-pharmacologist/00009259</link>
<description><![CDATA[Clinical Pharmacologist Location: Shanghai or Beijing
 Report line: Department head
 Company Profile
 This world reputable pharmaceutical company was founded in the late 1890s and employs more than 82,000 staff and sells its products in over 150 countries.&nbsp; Their therapeutic areas cover oncology, CNS, diabetes, cardiovascular and so on.
 As they will move their Asia Pacific headquarter from Sydney, Australia to Shanghai, China, internal employee expansion of China is on the to-do list.&nbsp; Also, more and more global projects, seminars, and other events will be poured into China.&nbsp; They set up their AP region headquarter in Shanghai while Beijing and Guangzhou are branch offices.
 Job Summary
- Be responsible for clinical pharmacology components of China regulatory submissions in either Clinical Trial Applications or NDA submission
 - In charge of high medical, scientific, and ethical standards to define the clinical pharmacology characteristics (safety, pharmacokinetics, and pharmacodynamics) of investigational drugs
 Responsibilities:
 - Provide clinical pharmacology expertise
 - Serve as a China liaison with Global Clinical Pharmacologist
 - Develop clinical pharmacology studies to support late-stage studies or NDA approvals in China
 - Deliver high-quality evaluation and interpretation of clinical pharmacology data
 - Deliver responses to regulatory agency questions, portion of the NDA documentation and preparation of materials
 - Provide support to train Data Managers, PK/PD Lab managers, Clinical Monitors for the Clinical Pharmacology studies
 Requirements:
 - Master degree or above in PHARMACOLOGY
 - Excellent communication skills both in English and Chinese
 - Around 3 years pharmacology experience on human is necessary
 - Practical experience on global trials is advantageous
 Apply now! Please contact Tom Tan on 86-21-23229600*2326 or email him via tom.tan@hays.cn.&nbsp; For more job info, please refer to www.hays.cn and www.hayspharma.com.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/italy/drug-safety-pharmacovigilance/medical-drug-safety-manager/893803</guid>
<pubDate>Sun, 11 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Medical & Drug Safety Manager]]></title>
<link>http://www.hayspharma.com/jobs/italy/drug-safety-pharmacovigilance/medical-drug-safety-manager/893803</link>
<description><![CDATA[Our Client, one of the most important European pharmaceutical firm specialized in the gastrointestinal therapeutic area, engaged us to find for its Italian affiliate a Medical &amp; Drug Safety Manager. &nbsp;
 The purpose of the role is to provide a medical / scientific support to the business activities and a drug safety support for the company’s investigational and marketed products.
 The potential candidate will be in charge of giving his/her contribute to the fulfillment of projects finalized to improve the efficacy and efficiency of Scientific Information concerning all medical operators, projecting and realizing potential trials (observational study too), performing all medical marketing activities and serving as primary point of contact for all local pharmacovigilance issues.
 The suitable candidate will be responsible for Field Force scientific training and will provide his/her support in collecting and processing SAEs for the submission of expedited reports to Health Authorities.
 Experience in clinical data design / execution and in drug safety issues will be necessary. The potential candidate, reporting to an International Medical Director, has a degree in Medicine and Surgery possibly with a post-graduate specialization in gastroenterology or internal medicine. A minimum of some experience in pharmaceutical or biotechnology company is preferred.
 I candidati di ambo i sessi, dopo aver visionato l'informativa obbligatoria sulla privacy sul sito www.hays.it, sono pregati di inviare il CV indicando il riferimento (Rif. 893803) oltre che il proprio consenso al trattamento dei dati personali ex D. LGS. 196/03&quot;.Aut. Min. N.13/I/007145/03.04 del 1 Aprile 2008.]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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<guid>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/associate-director-of-clinical-pharmacology-philadelphia/HQ00014797</guid>
<pubDate>Fri, 09 Jul 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Associate Director of Clinical Pharmacology - Philadelphia]]></title>
<link>http://www.hayspharma.com/jobs/usa/drug-safety-pharmacovigilance/associate-director-of-clinical-pharmacology-philadelphia/HQ00014797</link>
<description><![CDATA[Associate Director of Clinical Pharmacology required for our pharmaceutical client in the Philadelphia metro.

Our client, who are currently developing three new products, are looking for a senior drug development scientist with strong and documented written and verbal communication skills to step up to the position of Associate Director of Clinical Pharmacology. 

In this role the successful candidate will develop pharmacokinetic (PK) and pharmacodynamic (PD) methodologies to characterize human pharmacology and metabolism profiles of new drugs in development. They will also be expected to generate, evaluate and communicate study results to the business. Responsibilities will also include contributing PK/PD sections for IBs and global regulatory submissions. 

For this role you will be expected to scientifically support the clinical pharmacology and metabolism studies and advise the business in developments in pharmacokinetics, pharmacodynamics, pharmacogenomics and drug metabolism. 

To successfully apply for this role at a company rated as one of the best companies to work for in Pennsylvania, you should have a Ph.D. or Pharm.D. in pharmacokinetics, pharmacodynamics, pharmaceutical or biological sciences, or equivalent job training in relevant disciplines (e.g., Clinical Pharmacology, Clinical Pharmacokinetics, Pharmacometrics, etc.) with 3-5 years drug development experience in clinical pharmacology. Alternatively you can be MS degree educated with strong written and verbal communication skills with at least 8 years of relevant experience providing PK/PD support on drug development teams.

Additionally you should be able to demonstrate experience in using relevant analytical tools (e.g., WinNonlin, SAS, S-Plus), be able to prepare submission of documents and responses to Health Authority (HA) inquiries, to interpret and present study results to project teams, management and Has and be able to manager and motivate a team]]></description>
<category><![CDATA[Drug Safety & Pharmacovigilance]]></category>
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