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Director of Pharmacovigilance
2 months ago
About the Role
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.
Key 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.
- Collaborate with other R&D/cross-functional teams to ensure execution of the safety strategy.
- Contribute to clinical documents, including study protocols, informed consent forms, and regulatory submissions.
- Lead and chair the cross-functional Product Safety Group and present decisions to senior safety governance committees.
- Perform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products.
- Be accountable for medical evaluation/interpretation of aggregate safety data, including signal detection and evaluation.
- Perform signal management activities, such as signal validation, QC, and authoring of complex signal evaluations.
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs).
- Represent PV in cross-functional Product Label Working Group and lead evaluation and determination of safety-related sections of the product label.
- Provide PV support and safety contributions to Health Authority submissions and responses.
- Collaborate with different functional stakeholders in Teva and outside Teva effectively representing PV position on any safety concerns.
Requirements
- MD degree or equivalent.
- General practitioner license; certification/background in neurology is a plus.
- 3 years of minimum working experience in pharmacovigilance and drug safety area as a safety physician.
- Experience in managing safety issues in pre- or post-marketing environment.
- 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.
About Teva Pharmaceuticals
Teva Pharmaceuticals is a leading global pharmaceutical company dedicated to improving the health and well-being of people around the world. We are committed to delivering high-quality medicines and innovative solutions to address the complex healthcare challenges of today and tomorrow.
