Pharmacovigilance Director
1 month ago
Teva Pharmaceuticals is a leading manufacturer of innovative and generic medicines, and we're on a mission to make good health more affordable and accessible. We're seeking a highly skilled Director Pharmacovigilance - Safety Physician to join our Medical Scientific Unit (MSU) and support safety in our innovative products in pre- and post-marketing environments.
The OpportunityAs a Director Pharmacovigilance - Safety Physician, you will lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post-marketing. This includes company-sponsored studies, investigator-sponsored studies, compassionate use, and disease monitoring programs. You will perform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products from clinical trials.
Responsibilities- Lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post-marketing.
- Perform medical review and assessment of ICSRs for assigned products from clinical trials.
- Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety reviews/assessments.
- Perform signal management activities, such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review.
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures, and management of these plans throughout the product's lifecycle.
- Collaborate with different functional stakeholders in Teva (Medical Affairs, Clinical Development, Quality, etc.)
- Guide, provide support, and train, as applicable, safety physicians and safety scientists across safety surveillance activities, such as medical review, signal detection, and risk evaluation activities.
- Perform due diligence on product safety profile of potential new assets.
- 3 years of minimum working experience in pharmacovigilance and drug safety area as a safety physician with experience in managing safety issues in pre- or post-marketing environments.
- Experience in drug development is a plus.
- Strong knowledge of FDA and EMA regulations (GVP, GCP).
- Experience with NDA/BLA submissions in the US and MAA in Europe is a plus.
- Experience in managing safety due diligence of pharmaceuticals is a plus.
- Ability to work cross-functionally with an international team across multiple time-zones.
- Excellent communication skills in speaking and writing English.
MSU Team Leader (based in USA)
Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally recognized status entitled to protection under applicable laws. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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