Aktuelle Jobs im Zusammenhang mit Senior Pharmacovigilance Lead - Zug, Zug - JobMarket

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Senior Pharmacovigilance Lead

vor 1 Woche

Zug, Zug, Schweiz JobMarket Vollzeit
Job Description

The Senior Pharmacovigilance Lead will oversee PV Scientist(s) assigned to designated products, focusing on signal management, safety data evaluation, and regulatory document authoring.

  • Leading the signal management process for assigned product(s)
  • Evaluating safety data and signals through synthesis of multiple sources and authoring signal evaluation reports
  • Leading signaling review process and product Safety Signaling Team meetings as well as cross-functional project meetings
  • Responding to safety questions from regulatory authorities
  • Providing strategic input to regulatory document authoring, including PSURs, DSURs, PADERs, Addendum to Clinical Overview
  • Developing Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs)
  • Strategizing medical and scientific literature review for safety information
  • Safety leadership in regulatory submissions with Global Safety Officer collaboration
  • Maintaining up-to-date understanding of relevant global safety regulations and guidelines
  • Collaboration with Global Safety Officers and other Safety MDs for assigned investigational programs, including clinical trial activities