Pharmacovigilance Director
9 hours ago
Teva Pharmaceuticals is seeking a highly skilled Director of Pharmacovigilance to join our Medical Scientific Unit (MSU). As a key member of our team, you will play a critical role in ensuring the safety of our innovative products throughout their lifecycle.
About the Role- Lead the determination of the safety profile and characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post-marketing.
- Perform medical review and assessment of Individual Case Safety Reports (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, regulatory safety reports, and ad-hoc safety reviews.
- Lead signal management activities, such as signal validation, authoring of complex signal evaluations, and signal evaluation review.
- Contribute to the preparation of Risk Management Plans (RMPs), REMS, and design of additional risk minimization measures.
- Minimum 3 years of experience in pharmacovigilance and drug safety as a safety physician.
- Experience in managing safety issues in pre- or post-marketing environments.
- Strong knowledge of FDA and EMA regulations (GVP, GCP).
- Experience with NDA/BLA submissions in the US and MAA in Europe is a plus.
- Ability to work cross-functionally with an international team across multiple time-zones.
- Excellent communication skills in speaking and writing English.
- Competitive compensation and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
- Recognition programs to reward employees for their contributions.
Teva Pharmaceuticals is committed to equal opportunity in employment and is an equal opportunity employer. We welcome applications from diverse candidates and are proud to be an inclusive and diverse workplace.
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Pharmacovigilance Director
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Harlow, Essex, United Kingdom Teva Pharmaceuticals Full timeJob DescriptionJob Title: Pharmacovigilance DirectorCompany: Teva PharmaceuticalsJob Summary:We are seeking a highly skilled Pharmacovigilance Director to join our Medical Scientific Unit (MSU) at Teva Pharmaceuticals. As a key member of our team, you will be responsible for leading safety activities across our entire product portfolio and throughout various...
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