Head of Signal Evaluation

vor 1 Woche

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

About the Role

We are seeking a highly skilled and experienced professional to fill the position of Head of Signal Evaluation & Clinical Trial Safety. As a key member of our Product Safety Leadership Team, you will play a crucial role in the development and success of our organization.

Key Responsibilities

  • Lead and develop a team of six employees, overseeing the planning and responsibility of the dedicated budget.
  • Shape clinical development programs of our neurotoxin and other future products from a safety perspective.
  • Proactively improve ongoing processes and design new global (EU and RoW) processes within your area of responsibility.
  • Ensure the safety of our drugs by means of state-of-the-art signal management, including signal detection/signal evaluation processes for marketed products and products in clinical development.
  • Contribute to the preparation and follow-up of audits and inspections.
  • Contact person for regulatory inquiries and inquiries from subsidiaries regarding drug safety.

Requirements

  • Studies in human or veterinary medicine (ideally with a PhD) or university degree in natural sciences paired with several years of professional experience in product/drug safety.
  • Several years of professional experience in a research-based pharmaceutical company or in a CRO.
  • Experience in clinical development, ideally including submissions for marketing approval.
  • Solid pharmacovigilance (PV) experience and a strong understanding of PV regulation.
  • Track record of leading, motivating, and developing a team.
  • Knowledge of using a safety database (e.g., ARISg, Oracle ARGUS).
  • Very good knowledge of German and English.

About Us

Welcome to Merz Therapeutics, a leading pharmaceutical company dedicated to helping 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 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.

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