Global Pharmacovigilance Director

hace 19 horas

Zaragoza, Zaragoza, España Tevapharm A tiempo completo

Job Summary

As a key member of the Medical Scientific Unit (MSU) at Teva Pharmacovigilance, we are seeking a highly skilled Safety Physician and Director to lead our safety profile efforts. This is an exciting opportunity to work with a talented team of scientists and physicians to identify and mitigate risks associated with our products.

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.
  • 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.
  • 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, as applicable, PV scientists across safety surveillance activities.
  • Collaborate with different functions both in Teva and outside Teva.
  • Support global launch activities for assigned products.
  • Perform due diligence on product safety profile of potential new assets.

Requirements
  • 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.
  • 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.
  • Ability to work cross-functionally with an international team across multiple time-zones.
  • Excellent communication skills in speaking and writing English.

About Us
Teva Pharmacovigilance is a leading manufacturer of generic medicines and a proud producer of many of the products on the World Health Organization's Essential Medicines List. We are committed to making good health more affordable and accessible to millions around the world.

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