Global Safety Physician (freelance)

Responsibilities

Qualification:

Framework Data:

• Performing and documenting the medical review of Serious Adverse Events (SAEs) in ongoing interventional clinical studies with approved and not yet approved drugs
• Medical assessment of already identified safety signals regarding their clinical relevance and potential impact on the safety profile of the respective drugs
• Performing the medical review of safety-relevant study documents, especially study protocols and Investigator's Brochures (IBs)
• Medical review and professional commentary on regulatory safety reports, especially Annual Safety Reports and Periodic Safety Update Reports (PSURs)
• Developing well-founded medical assessments on product-specific safety issues as a professional basis for decision-making for the responsible pharmacovigilance specialists
• Professional assessment of further study-related safety information as well as documentation of medical assessments and review results
• Completed university degree in human medicine
• Several years of relevant professional experience in pharmacovigilance or clinical drug safety, ideally as a Safety Physician, Drug Safety Physician, or Medical Safety Reviewer
• Sound practical experience in the medical review and assessment of SAEs from interventional clinical studies
• Experience in the medical assessment of safety signals (Signal Assessment) and the evaluation of product-specific safety risks
• Experience in the medical review of clinical study documents as well as regulatory safety reports (e.g., study protocols, IBs, Annual Safety Reports and PSURs)
• Sound knowledge of regulatory requirements in the field of clinical drug safety and pharmacovigilance, especially GCP and GVP
• Ability for independent medical assessment of complex safety-relevant issues and for comprehensible communication of medical assessments to non-medical experts

Project details

Asap, at the latest November 2026

6 months

Weekly Hours: Average approx. 10 hours/week (0.25 FTE), up to 20 hours/week (0.5 FTE) if needed, flexible workload on an hourly contingent basis

• Start: ab sofort
• Remote: remote
• Location: Deutschland, Deutschland, DE
• Languages: German