Pharmacovigilance Director

2 days ago

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

At Teva Pharmaceuticals, we are seeking a highly skilled Director Pharmacovigilance - Safety Physician to join our Medical Scientific Unit (MSU). This role will support safety in our innovative products across the pre- and post-marketing environment.

About the Role

The successful candidate will lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products during clinical development and/or post-marketing. This includes company-sponsored studies, investigator-sponsored studies, compassionate use, and disease monitoring programs.

Key Responsibilities
  • Perform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products from clinical trials.
  • Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, dose escalation evaluations, regulatory safety reports, and ad-hoc safety reviews/assessments.
  • Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, and design of additional risk minimization measures.
  • Collaborate with different functional stakeholders in Teva, including Medical Affairs, Clinical Development, Quality, and others.
  • Guide, provide support, and train safety physicians and safety scientists across safety surveillance activities.
Requirements
  • Minimum 3 years of working experience in pharmacovigilance and drug safety area as a safety physician.
  • Experience in managing safety due diligence of pharmaceuticals is a plus.
  • Excellent communication skills in speaking and writing English.

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