Global Pharmacovigilance Lead

hace 1 semana


Zaragoza, Zaragoza, España Tevapharm A tiempo completo
Job Summary

We are seeking a skilled Safety Physician to lead the pharmacovigilance efforts for our Teva Pharmaceuticals unit. As a key member of the Medical Scientific Unit, you will play a critical role in ensuring the safety and efficacy of our products throughout their lifecycle.

About Teva

Teva Pharmaceuticals is a leading manufacturer of generic medicines and proud producer of many products on the World Health Organization's Essential Medicines List. Our mission is to make good health more affordable and accessible, helping millions around the world enjoy healthier lives.

Responsibilities
  • Lead the safety profile of assigned products during clinical development, including company-sponsored studies, investigator-sponsored studies, compassionate use, and disease monitoring programs.
  • Contribute to clinical documents, such as protocols, IBs, informed consent/assent forms, clinical study reports, integrated summaries of safety, CTD submissions, regulatory agency responses, IRB/EC requests, briefing books, and other relevant safety-related clinical documents.
  • Lead and chair cross-functional product safety groups.
  • Perform medical review of ICSRs for assigned products from clinical trials.
  • Accountable for medical evaluation/interpretation of aggregate safety data of assigned products.
  • Lead risk management activities for assigned products globally.
  • Represent PV on the cross-functional product label working group.
  • Guide, provide support, and train PV scientists across safety surveillance activities.
  • Collaborate with different functions both within and outside Teva.
  • Support global launch activities for assigned products.
  • Perform due diligence on product safety profiles of potential new assets.
Requirements
  • MD or equivalent degree.
  • Completion of an accredited residency/specialty program and board certification or eligibility.
  • 5-year minimum experience working in pharmacovigilance and drug safety area as a safety physician.
  • 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 ability to handle safety surveillance tasks.
  • Ability to work cross-functionally with an international team across multiple time zones.
  • Excellent communication skills in speaking and writing English.
Salary Estimate

The estimated salary for this position is €120,000 - €180,000 per annum, based on the location in Madrid, Spain.



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