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. This role evaluates clinical safety data, supports signal detection and risk management, and contributes to ongoing benefit‑risk assessments.

Key responsibilities

• Perform physician‑level medical review of serious adverse events, adverse events of special interest, medically significant events, and other trial safety data.
• Conduct causality, seriousness, and expectedness assessments and review safety narratives.
• Collaborate with pharmacovigilance vendors and internal partners to monitor emerging safety trends from case reports, trial data, literature, and other sources.
• Contribute to signal detection, validation, evaluation, and risk mitigation planning for investigational products.
• Support benefit‑risk assessments for assigned clinical development programs.
• Participate in safety governance forums such as Safety Management Team meetings and Safety Review Committees.
• Prepare and review clinical safety deliverables including DSURs, SAE narratives, line listings, safety surveillance outputs, and aggregate safety summaries.
• Provide safety input into protocols, investigator brochures, informed consent forms, clinical study reports, risk management plans, regulatory submissions, and health authority responses.
• Ensure timely escalation, documentation, and communication of safety issues to internal stakeholders, investigators, ethics committees, and regulators.
• Maintain compliance with pharmacovigilance regulations, ICH guidelines, GCP, company SOPs, and trial safety reporting requirements.

Required profile

• MD (or equivalent) required; board certification or specialty training preferred.
• Fluency in Mandarin Chinese.
• Experience in pharmacovigilance within biotech, pharma, or CRO environments.
• Strong understanding of ICH guidelines, GCP, pharmacovigilance regulations, and clinical trial safety reporting.
• Experience reviewing serious adverse events, clinical safety data, aggregate safety data, and benefit‑risk information.
• Familiarity with signal detection, safety surveillance, DSURs, investigator brochures, and clinical study documentation.

Required skills