Director of Global Pharmacovigilance
hace 1 mes
Unlock the Future of Drug Safety
Teva Pharmaceuticals is seeking a highly skilled and experienced Director of Global Pharmacovigilance to join our Medical Scientific Unit (MSU) and lead the safety profile of our products throughout the entire product lifecycle.
About the Role
- Lead the safety profile of assigned products during clinical development, including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use, and Disease Monitoring Programs.
- Collaborate with other R&D teams to ensure execution of the safety strategy.
- Contribute to clinical documents, such as protocols, IBs, informed consent/assent forms, clinical study reports, integrated summaries of safety, and Common Technical Document (CTD) submissions.
- Lead and chair the cross-functional Product Safety Group, responsible for presenting decisions to senior governance committees and Teva's top management.
- Perform medical review of ICSRs for assigned products from clinical trials.
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments.
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, and management of these plans throughout the product lifecycle.
- Represent PV on the cross-functional Product Label Working Group, leading evaluation and determination of safety-related sections of the product label, both initial and throughout the product lifecycle.
- Guide, provide support, and train PV scientists across safety surveillance activities, such as medical review, signal detection, and risk evaluation.
- Collaborate with different functions both in Teva and outside Teva to effectively communicate PV position on any safety concerns and the overall safety profile of assigned products.
- Support global launch activities for assigned products.
- Perform due diligence on product safety profile of potential new assets.
About You
- MD or equivalent degree.
- Completion of an accredited Residency/Specialty program and Board Certification or Eligibility.
- 5-year minimum working in pharmacovigilance and drug safety area as a safety physician.
- Experience in drug development, immunology, or neurology therapeutic areas is a plus.
- Strong knowledge of FDA and EMA regulations (GVP, GCP).
- Experience with NDA/BLA submissions in the US and MAA in Europe.
- Experience in managing safety issues in pre-and post-marketing environments.
- Proven abilities in handling safety surveillance tasks and chairing safety committee meetings.
- Ability to work cross-functionally with an international team across multiple time-zones.
- Excellent communication skills in speaking and writing English.
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