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Pharmacovigilance Director
2 months ago
About the Role
Teva Pharmaceuticals is seeking a highly skilled Pharmacovigilance Director to join our Medical Science Unit (MSU) team. As a key member of our safety team, you will play a critical role in ensuring the safe use of our innovative products in pre- and post-marketing environments.
Key Responsibilities
- Lead Safety Activities: 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, including company-sponsored studies, investigator-sponsored studies, compassionate use, and disease monitoring programs.
- Medical Review and Assessment: You will perform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products from clinical trials.
- Signal Detection and Evaluation: You will 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.
- Signal Management: You will perform signal management activities, such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. You will also act as a medical reviewer to assess causality and consolidate safety information from different sources to determine whether a signal qualifies as a risk.
- Risk Management: You will 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.
- Collaboration and Training: You will collaborate with different functional stakeholders in Teva (Medical Affairs, Clinical Development, Quality, etc.) and guide, provide support, and train, as applicable, safety physicians and safety scientists across safety surveillance activities.
- Due Diligence: You will perform due diligence on product safety profiles of potential new assets.
Requirements
- Experience: 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.
- Regulatory Knowledge: Strong knowledge of FDA and EMA regulations (GVP, GCP).
- Submission Experience: Experience with NDA/BLA submissions in the US and MAA in Europe is a plus.
- Communication Skills: Excellent communication skills in speaking and writing English.
What We Offer
- Competitive Compensation: We offer a competitive salary and benefits package.
- Opportunities for Growth: We provide opportunities for professional growth and development.
- Diverse and Inclusive Environment: We foster a diverse and inclusive work environment.