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


  • Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Job Title: Head of Signal Evaluation & Clinical Trial SafetyAbout the Role:We are seeking a highly skilled and experienced professional to lead our Signal Evaluation & Clinical Trial Safety team. As Head of Signal Evaluation & Clinical Trial Safety, you will be responsible for ensuring the safety of our drugs by means of state-of-the-art signal management,...


  • Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

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  • Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Unlock Your Potential as a Global Product Safety LeaderJoin Merz Therapeutics, a leading pharmaceutical company, as we seek a highly skilled and experienced professional to lead our Signal Evaluation and 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,...


  • Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Unlock Your Potential as a Global Product Safety LeaderJoin Merz Therapeutics, a leading pharmaceutical company, as we seek a highly skilled and experienced professional to lead our Signal Evaluation and Clinical Trial Safety team. As a key member of our Product Safety Leadership Team, you will play a critical role in shaping the global product development...


  • Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit

    Unlock Your Potential as a Global Product Safety LeaderJoin Merz Therapeutics, a leading pharmaceutical company, as we seek a highly skilled and experienced professional to lead our Signal Evaluation and Clinical Trial Safety team. As a key member of our Product Safety Leadership Team, you will play a critical role in shaping the global product development...


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Head of Signal Evaluation and Clinical Trial Safety

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
{"title": "Head of Signal Evaluation and Clinical Trial Safety", "subtitle": "Join our team at Merz Therapeutics", "content": "

We are seeking a highly skilled and experienced professional to lead our signal evaluation and clinical trial safety efforts. As Head of Signal Evaluation and Clinical Trial Safety, you will be responsible for ensuring the safety of our drugs through state-of-the-art signal management, including signal detection and evaluation processes for marketed products and products in clinical development.

You will own the overall safety strategy and ongoing risk-benefit assessment, ensuring the quality of regulatory documents, such as PSURs, EU Risk Management Plans, and DSURs. Additionally, you will contribute to the preparation and follow-up of audits and inspections, and serve as the contact person for regulatory inquiries and inquiries from subsidiaries regarding drug safety.

To be successful in this role, you will need to have a strong understanding of pharmacovigilance regulation and a track record of leading, motivating, and developing a team. You will also need to have experience in clinical development, ideally including submissions for marketing approval, and a solid knowledge of using a safety database, such as ARISg or Oracle ARGUS.

We offer a hybrid work model that allows for a good work-life balance, an attractive location with good transport links, modern workplaces, and a company restaurant. You will also have the opportunity to work in a global family business with flat hierarchies and an open, respectful corporate culture.

Apply now to become part of our international and motivated Merz Therapeutics family and help us achieve our goal: "Better outcomes for more patients."

", "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
", "benefits": "
  • Individual career development in a purposeful job: you improve 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
", "language": "en-US"}