Head of Clinical Safety

vor 1 Tag


München, Deutschland Meet Life Sciences Vollzeit

Job Description – Head of Clinical Safety Position: Head of Clinical Safety Functional Unit: Drug Safety / Global Clinical Development Note: Disciplinary and/or technical reporting lines are defined in the current, signed organisational chart and may be subject to change. Prerequisites and Requirements Advanced degree in life sciences, pharmacy, or medicine (MD or veterinary degree preferred). Minimum of 10 years’ experience in Clinical Development, including at least 5 years in Clinical Safety. Experience in oncology and/or immuno-oncology preferred. Significant experience in strategic safety activities, including signal management, risk assessment, safety data review, and interactions with regulatory authorities (US and EU). Strong knowledge of regulatory requirements related to GCP and clinical safety. Demonstrated managerial skills with experience building and leading a Clinical Safety function. Experience with safety databases (commercial safety databases preferred). Proficiency in English with excellent written communication skills. Full-time availability, with a preference for partial on-site presence during the working week. Tasks and Responsibilities Collaborate cross-functionally with internal stakeholders and external vendors. Ensure high-quality safety management within a growing biotechnology organisation. Lead and mentor team members and peers on all clinical safety–related topics. Manage safety vendors and ensure appropriate sponsor oversight of outsourced activities. Author, maintain, and update safety-related SOPs, templates, and forms. Ensure inspection readiness and act as internal lead during safety inspections.


  • Safety Manager

    vor 1 Tag


    München, Deutschland Meet Life Sciences Vollzeit

    Job Summary The Senior Manager of Drug Safety supports drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies. Responsibilities include initial safety review of adverse events, medical review of clinical data, interaction with external drug safety vendors, review of source...


  • München, Deutschland Meet Life Sciences Vollzeit

    Job Summary The Senior Manager of Drug Safety supports drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies. Responsibilities include initial safety review of adverse events, medical review of clinical data, interaction with external drug safety vendors, review of source documents,...


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  • München, Deutschland Meet Life Sciences Vollzeit

    Overview We are seeking an experienced Medical Director or Senior Director to act as the Global Medical Lead for a Liver Cancer (Hepatocellular Carcinoma) clinical development program. This role carries overall medical accountability for the study and will focus on strategic clinical leadership , supported by two contract Medical Monitors . The role sits...


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  • Eu Medical Writer

    vor 1 Woche


    München, Deutschland Syneos - Clinical and Corporate - Prod Vollzeit

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