Merck Group Hiring Lead Pharmacovigilance Expert

Merck Group Hiring Lead Pharmacovigilance Expert

15 June, 2022

Merck Group Hiring Lead Pharmacovigilance Expert

JD

As Lead Pharmacovigilance Expert you will join our Global Patient Safety Regions team in preparing local risk management plans and local safety related reports.

Your key responsibilities are:

  • Understand the benefit risk profile and safety strategy for multiple products across different therapeutic areas (e.g. oncology, neurology, cardiology, etc.)
  • Interact with Safety Strategy Leads with the same medical knowledge and expertise to accurately describe the risks and associated risk minimization measures in risk management plans
  • Prepare local risk management plans and local safety reports according to the local regulations and ensure timely delivery of all local risk management plans and local safety reports
  • Manage stakeholder expectations from cross-functional reviewers including patient safety, regulatory affairs and medical affairs
  • Maintain local risk management plan and local safety report requirements and templates including the review of impact assessments related to changes/new PV regulations on risk management plans and safety reports

Who you are:

  • You have a medical and/or advanced scientific degree (Ph.D.) in health or life sciences and at least 10 years of experience in the pharmacovigilance environment
  • You have an excellent understanding of regulations relevant to the safety of drugs in post-authorization and development
  • You have extensive experience in preparing local risk management plans according to local requirements and a background in medical writing
  • Advanced communication skills and experience in an international environment are equally important as well as intercultural experience through successful collaboration in matrix teams
  • Strong project management and organizational skills
  • Experience as a Safety Strategy Lead or equivalent is an advantage
  • Fluent in English, and an additional foreign language would be beneficial (e.g. Spanish, Portuguese, German).

Apply HERE

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