Drug Safety Physician

About the Role The Drug Safety Physician will provide medical and scientific oversight for pharmacovigilance activities across clinical development programs and investigational products. This role will evaluate individual and aggregate clinical safety data, support signal detection and risk management activities, and contribute to ongoing benefit-risk assessment. The Drug Safety Physician will partner with Clinical Development, Regulatory Affairs, and other cross-functional teams to support timely identification, escalation, and communication of safety issues, emerging trends, and potential risks in accordance with study protocols, company procedures, and applicable regulatory requirements. Title and level will be determined based on the candidate’s qualifications, experience, and scope of responsibility. Responsibilities Provide physician-level medical review and assessment of serious adverse events, adverse events of special interest, medically significant events, and other clinical trial safety data. Perform or support causality assessment, seriousness assessment, expectedness evaluation, and medical review of safety narratives, as appropriate. Work closely with PV vendor and partners to monitor emerging safety trends through ongoing review of individual case safety reports, clinical trial data, literature, and other relevant clinical safety sources. Contribute to signal detection, signal validation, signal evaluation, and risk mitigation planning for investigational products. Support benefit-risk assessments for assigned clinical development programs. Participate in safety governance forums, including Safety Management Team meetings, Safety Review Committees, and other cross-functional safety discussions. Prepare, review, or provide medical input into clinical safety deliverables, including DSURs, SAE narratives, line listings, safety surveillance outputs, and aggregate safety summaries. Provide safety input into clinical study protocols, investigator brochures, informed consent forms, clinical study reports, risk management plans, regulatory submissions, and responses to health authority inquiries. Ensure safety issues are appropriately escalated, documented, and communicated to internal stakeholders, study teams, investigators, ethics committees, and regulatory authorities as required. Maintain compliance with applicable pharmacovigilance regulations, ICH guidelines, GCP, company SOPs, and clinical trial safety reporting requirements. Qualifications MD (or equivalent) required; board certification or specialty training preferred. Fluency in Mandarin Chinese. Experience in pharmacovigilance within biotech, pharma, or CRO Strong understanding of ICH guidelines, GCP, pharmacovigilance regulations, and clinical trial safety reporting requirements. Experience reviewing serious adverse events, clinical safety data, aggregate safety data, and benefit-risk information. Familiarity with signal detection, safety surveillance, DSURs, investigator brochures, clinical study reports, safety narratives, and regulatory submissions. Ability to interpret complex medical and scientific data and communicate safety findings clearly to cross-functional stakeholders. Strong attention to detail, documentation practices, and ability to manage multiple priorities in a high-paced environment. Show more Show less