SERM/Safety Evaluation & Risk Management Physician
Core
Responsible for continuous safety assessment, risk management, and medical review of GSK Japan products in clinical development and post-marketing settings to ensure patient safety.
Role type
Senior clinical physician (pharmacovigilance/safety)
Builds
Safety management initiatives and regulatory submissions for GSK Japan products
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical knowledge, patient care management, benefit/risk evaluation, independent clinical assessment, integrity, resilience
Preferred skills
Epidemiology, public health, large dataset analysis, leadership, academic publishing
Technologies
None stated
Responsibilities
Perform risk identification, assessment, and mitigation throughout product lifecycle; Medical review of individual case safety information and periodic safety data; Ensure quality of documents submitted to regulatory authorities; Contribute to safety aspects for new drug applications and negotiate with regulatory authorities; Participate in safety-related meetings; Provide medical advice on safety-related aspects to colleagues across GSK Japan and Global
Seniority
Senior, hands-on IC
