Director of Global Pharmacovigilance

hace 2 días

Zaragoza, Zaragoza, España Tevapharm A tiempo completo
Job Title: Director Global Pharmacovigilance

We are seeking a highly skilled and experienced Director of Global Pharmacovigilance to join our team at Teva Pharmaceuticals. As a key member of our Medical Scientific Unit (MSU), you will play a critical role in leading drug safety across our entire portfolio and throughout the product lifecycle.

About the Role:

In this position, you will lead the safety profile of assigned products during clinical development, including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. You will contribute to clinical documents, such as protocols, informed consent forms, clinical study reports, and Common Technical Document (CTD) submissions. Additionally, you will lead and chair cross-functional Product Safety Groups, perform medical review of Individual Case Safety Reports (ICSRs), and be accountable for medical evaluation and interpretation of aggregate safety data.

Responsibilities:
  • Lead the safety profile of assigned products during clinical development
  • Contribute to clinical documents, including protocols, informed consent forms, and clinical study reports
  • Lead and chair cross-functional Product Safety Groups
  • Perform medical review of ICSRs
  • Be accountable for medical evaluation and interpretation of aggregate safety data
  • Represent PV on the cross-functional Product Label Working Group
  • Guide and train 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 degree
  • Completion of an accredited Residency/Specialty program and Board Certification or Eligibility
  • 5 years of experience 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 in 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 Teva Pharmaceuticals:

Teva Pharmaceuticals is committed to equal opportunity in employment and is an equal opportunity employer. We are a leading manufacturer of generic medicines and a proud producer of many of the products on the World Health Organization's Essential Medicines List.

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