Global Medical Safety Physician

About the role

The Global Medical Safety Physician will lead and support safety signal detection and assessment across our drug development portfolio. This senior medical role ensures rigorous clinical safety evaluation, regulatory reporting, and collaboration with cross‑functional teams.

Key responsibilities

• Lead the end‑to‑end signal detection process, from identification to final assessment and regulatory documentation (PADER, DSUR).
• Review and assess clinical trial safety data, providing detailed medical evaluations and clinical assessments.
• Analyze diverse clinical and safety data sources to ensure thorough analysis and accurate reporting.
• Participate in safety monitoring of clinical trials, working with protocols, Investigator’s Brochures (IB), Informed Consent Forms (ICF), and medical monitors.
• Support drug development teams with safety expertise throughout clinical development.
• Contribute to regulatory submissions and filings where applicable.

Required profile

• Medical degree (physician) preferred.
• Strong experience in signal detection, aggregate reporting, and preparation of regulatory documents such as PADER and DSUR.
• Deep knowledge of the full lifecycle of signal detection to final assessment.
• Experience with clinical trial safety monitoring and familiarity with trial protocols, IBs, ICFs, and medical monitoring.
• Exposure to immunology and gene therapy is a significant advantage.

Required skills

• Signal detection
• Aggregate reporting
• Regulatory document preparation (PADER, DSUR)
• Clinical trial safety monitoring
• Clinical trial protocol review
• Investigator’s Brochure (IB) review
• Informed Consent Form (ICF) review
• Medical monitoring