Pharmacovigilance Director

2 days ago

Harlow, Essex, United Kingdom Tevapharm Full time
Director Pharmacovigilance - Safety Physician

Teva Pharmaceuticals is seeking a highly skilled Director Pharmacovigilance - Safety Physician to join our Medical Scientific Unit (MSU). As a key member of our team, you will play a critical role in ensuring the safety of our innovative products throughout their lifecycle.

About the Role

As a Director Pharmacovigilance - Safety Physician, you will be responsible for leading activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products. This will include medical review and assessment of Individual Case Safety Reports (ICSRs), signal detection and evaluation, and risk management activities.

Key Responsibilities
  • Lead medical review and assessment of ICSRs for assigned products
  • Perform signal detection and evaluation, including signal validation QC and authoring of complex signal evaluations
  • Contribute to the preparation of Risk Management Plans (RMPs) and REMS
  • Collaborate with different functional stakeholders in Teva, including Medical Affairs, Clinical Development, and Quality
  • Guide, provide support, and train safety physicians and safety scientists across safety surveillance activities
Requirements
  • 3 years of minimum working experience in pharmacovigilance and drug safety area as a safety physician
  • Experience in managing safety issues in pre- or post-marketing environment
  • Strong knowledge of FDA and EMA regulations (GVP, GCP)
  • Experience with NDA/BLA submissions in the US and MAA in Europe is a plus
  • 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. We are a global leader in the pharmaceutical industry, dedicated to making good health more affordable and accessible. Our mission is to help millions around the world enjoy healthier lives.

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