Director of Global Pharmacovigilance

hace 1 día

Madrid, Madrid, España Teva Pharmaceuticals A tiempo completo
The Opportunity

Teva Pharmaceuticals is seeking a highly skilled and experienced physician to join our Pharmacovigilance unit as a Director of Global Pharmacovigilance. In this role, you will be responsible for leading the safety profile of assigned products during clinical development, collaborating with other R&D teams to ensure execution of the safety strategy, and contributing to clinical documents.

The Location

This role can be based in any European country where Teva has offices/sites.

Key Responsibilities
  • 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 protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, and other relevant safety-related clinical documents.
  • 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 of assigned and other products.
  • Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans throughout the product's life cycle.
  • 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, as applicable, PV scientists across safety surveillance activities, such as medical review, signal detection, and risk evaluation activities.
  • Collaborate with different functions both in Teva (Medical Affairs, Clinical Development, Quality, etc.) and outside Teva (KOLs, CROs, etc.) to effectively communicate PV position on any safety concerns as well as 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.
Your Experience and Qualifications
  • MD or equivalent.
  • Completion of an accredited Residency/Specialty program and is Board Certified or Eligible.
  • 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 environment.
  • Proven abilities on 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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