Drug Safety Physician

About the role

The Drug Safety Physician provides medical and scientific oversight for pharmacovigilance activities across clinical development programs and investigational products. You will evaluate clinical safety data, support signal detection, risk management, and contribute to benefit‑risk assessments.

Key responsibilities

• Perform physician‑level medical review of serious adverse events, adverse events of special interest, and other safety data.
• Conduct causality, seriousness, and expectedness assessments and review safety narratives.
• Collaborate with PV vendors and cross‑functional teams to monitor emerging safety trends from case reports, literature, and trial data.
• Support signal detection, validation, evaluation, and risk mitigation planning.
• Contribute to benefit‑risk assessments for assigned programs and participate in safety governance forums.
• Prepare or review clinical safety deliverables such as DSURs, SAE narratives, line listings, safety surveillance outputs, and aggregate summaries.
• Provide safety input into protocols, investigator brochures, informed consent forms, risk management plans, and regulatory submissions.
• Ensure timely escalation, documentation, and communication of safety issues to internal and external stakeholders.

Required profile

• MD (or equivalent) required; board certification or specialty training preferred.
• Fluency in Mandarin Chinese preferred.
• 3–5+ years of pharmacovigilance experience in biotech, pharma, or CRO.
• Strong understanding of ICH guidelines, GCP, and pharmacovigilance regulations.
• Experience reviewing serious adverse events, aggregate safety data, and benefit‑risk information.

Required skills

• Pharmacovigilance
• ICH guideline implementation
• Good Clinical Practice (GCP)
• Signal detection and validation
• Safety surveillance and DSUR preparation
• Causality and seriousness assessment
• Medical review of safety narratives