Patient Safety Physician

About the role

The Patient Safety Physician will support the safety monitoring of pharmaceutical products by reviewing adverse event cases, ensuring regulatory compliance, and providing medical expertise to internal and external stakeholders.

Key responsibilities

• Maintain a working knowledge of adverse event safety profiles, labeling, data handling conventions, and global drug safety regulations.
• Stay aware of global regulatory requirements and reporting obligations, organizing workload to meet internal and regulatory timelines.
• Communicate review issues with line managers and project leaders, and interact with internal and external stakeholders to resolve safety questions.
• Attend and present at client and cross‑functional meetings under senior physician guidance.
• Perform medical review of spontaneous, clinical trial, literature, and combination product cases according to SOPs.
• Write pharmacovigilance comments, assess causality, seriousness, and expectedness of events.
• Provide medical inputs to case processing teams, raise follow‑up queries, and assign appropriate MedDRA codes.
• Identify and resolve case issues, coordinating with therapeutic and legal teams.
• Review or author aggregate safety reports (PBRER, PSUR, SER, DSUR, etc.) ensuring medical consistency.
• Support preparation of regulatory documents such as benefit‑risk evaluations and health authority responses.
• Answer day‑to‑day medical and scientific questions, providing daily support to staff and study sites.

Required profile

• Strong knowledge of adverse event safety profiles and global drug safety regulations.
• Experience in medical review of pharmacovigilance cases across various sources.
• Ability to assess causality, seriousness, and expectedness of reported events.
• Proficiency in communicating with stakeholders and preparing regulatory documentation.
• Familiarity with SOPs, MedDRA coding, and aggregate safety reporting.

Required skills

• MedDRA coding
• Pharmacovigilance case review
• Regulatory reporting
• Medical causality assessment
• Adverse event assessment
• Clinical safety documentation