Pharmacovigilance Specialist

vor 1 Monat


Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Global Pharmacovigilance Expert

Merz Therapeutics is seeking a highly skilled Global Pharmacovigilance Expert to join our team. As a key member of our Pharmacovigilance Group, you will play a crucial role in maintaining and shaping our international pharmacovigilance system.

Key Responsibilities:
  • Maintain and update the Pharmacovigilance System Master File (EEA/UK-PSMF)
  • Organize and perform internal and external pharmacovigilance trainings
  • Create and update local and global PV operating procedures and work instructions (SOPs, WIs)
  • Develop and maintain Safety Agreements for the exchange of safety-related information with Merz affiliates and partners
  • Commission and supervise vigilance service providers for outsourced vigilance activities
  • Monitor risk and referral procedures and coordinate resulting measures
  • Prepare and follow-up on PV audits and inspections
Requirements:
  • Degree in natural science or pharmacy
  • 5 years of experience in pharmacovigilance and understanding of PV legislation in Germany, Europe, and the UK
  • Knowledge in Regulatory Affairs for medicinal products
  • Willingness to engage in ongoing training for current drug safety practices
  • Fluent in written and spoken English and good knowledge of German
  • Strong communication and analytical skills
What We Offer:
  • Individual career development in a purposeful job
  • Hybrid work model for a good work-life balance
  • Attractive location with good transport links and modern workplaces
  • Global family business with flat hierarchies and an open corporate culture
  • Attractive remuneration with extensive social benefits


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