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Pharmacovigilance Director

2 months ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
Job Description

Job Title: Pharmacovigilance Director

Company: Teva Pharmaceuticals

Job Summary:

We are seeking a highly skilled Pharmacovigilance Director to join our Medical Scientific Unit (MSU) at Teva Pharmaceuticals. As a key member of our team, you will be responsible for leading safety activities across our entire product portfolio and throughout various stages of the product lifecycle.

Key Responsibilities:

  • 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.
  • 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, regulatory safety reports, and ad-hoc safety reviews/assessments.
  • Perform signal management activities, such as signal validation, authoring of complex signal evaluations, and signal evaluation review.
  • Act as a medical reviewer to assess causality and consolidate safety information from different sources to determine whether a signal qualifies as a risk.
  • 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, and Quality.
  • Guide, provide support, and train safety physicians and safety scientists across safety surveillance activities.
  • Perform due diligence on product safety profiles of potential new assets.

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.

Benefits:

  • 25 days of annual leave.
  • Pension scheme.
  • Company car or car allowance.
  • Life & Critical Illness Insurance.
  • Private health insurance for you and your family.
  • Sports and Health Programme.
  • On-site Canteen.
  • Recognition programs to reward employees with our company bonus scheme.
  • Virtual Learning Centre.