Pharmacovigilance Specialist

vor 1 Woche

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

About the Role

We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Merz Therapeutics. As a key member of our Pharmacovigilance Group, you will play a critical role in maintaining and shaping our international pharmacovigilance system for all drugs of Merz Therapeutics.

Key Responsibilities

  • Maintain and update the Pharmacovigilance System Master File (EEA/UK-PSMF)
  • Organize and perform internal and external pharmacovigilance trainings
  • Creation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)
  • Creating and updating Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide
  • Commissioning and supervision of vigilance service providers for outsourced vigilance activities as well as preparation and updating of the corresponding contracts
  • Monitoring of risk and referral procedures and coordination of the resulting measures, e.g. recalls / risk defense, in alignment with responsible functions
  • Active preparation and follow-up of PV audits and PV inspections and to ensure the implementation of resulting Corrective and Preventive Actions

Requirements

  • Degree in natural science or pharmacy (e.g., Diploma or Master's)
  • 5 years of experience in pharmacovigilance and understanding of PV legislation in Germany, Europe and the UK (e.g., AMG, AMWHV, GVP)
  • Knowledge in the field of Regulatory Affairs for medicinal products is necessary
  • Willingness to engage in ongoing training for current drug safety practices and GVP implementation
  • Confident handling of Microsoft Office package, if necessary knowledge in handling drug safety databases
  • Fluent in written and spoken English & good knowledge of German
  • Strong communication skills and ability to work in a team
  • Strong analytical skills and ability to work scientifically
  • Very careful, conscientious way of working
  • High level of resilience and self-organization

About Us

Merz Therapeutics is a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life. We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.

Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: \"BETTER OUTCOMES FOR MORE PATIENTS\"

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