Aktuelle Jobs im Zusammenhang mit Head of Signal Evaluation - Frankfurt am Main, Hessen - Merz Therapeutics


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Head of Signal Evaluation

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Job Summary

We are seeking a highly skilled and experienced professional to lead our Signal Evaluation & Clinical Trial Safety team. As a key member of our Product Safety Leadership Team, you will contribute to the development and success of our organization.

Key Responsibilities
  • Lead and develop a team of six employees, responsible for planning and managing the dedicated budget.
  • Shape clinical development programs from a safety perspective, ensuring the safety of our drugs through state-of-the-art signal management.
  • Proactively improve ongoing processes and design new global processes within your area of responsibility.
  • Ensure the safety of our drugs through thorough Health Hazard Evaluations, risk assessment, and evaluation of medical impact.
  • Ensure the quality of regulatory documents, such as PSURs, EU Risk Management Plans, and DSURs.
  • Contribute to the preparation and follow-up of audits and inspections.
  • Contact person for regulatory inquiries and inquiries from subsidiaries regarding drug safety.
  • Assess risks that may result from quality deficiencies.
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.
  • Highly independent analytical and conceptual way of working, as well as pleasure in designing and developing processes.
  • Independent and structured way of working with good time management, as well as a high degree of reliability.
What We Offer
  • Individual career development in a purposeful job, contributing to the quality of life of our patients.
  • Hybrid work model that allows a good work-life balance.
  • Attractive location with good transport links, modern workplaces, and a company restaurant.
  • Global family business with flat hierarchies and an open, respectful corporate culture.
  • Attractive remuneration with extensive social benefits.
  • Variety of employer-subsidized benefits such as Wellpass, Germany ticket, Corporate Benefits, and JobBike.