Senior Medical Safety Advisor

About the role

The Senior Medical Safety Advisor provides senior‑level medical and scientific leadership with a strong focus on pharmacovigilance and medical safety, supporting broader medical affairs and evidence activities across clinical and post‑marketing sources.

Key responsibilities

• Perform medical review of clinical trial and post‑marketing adverse events (AEs/SAEs/ADRs), including narrative writing, causality, seriousness, expectedness, coding and query management.
• Provide medical oversight for safety surveillance activities for assigned products.
• Prepare, review and contribute to aggregate safety reports such as DSURs, PBRERs, RMPs and ad‑hoc regulatory submissions.
• Author and medically review analyses of similar events (AOSE) and support signal detection activities.
• Review protocols, Investigator Brochures and case report forms for safety content and data capture.
• Serve as a medical expert and internal consultant to pharmacovigilance, real‑world evidence and project teams.
• Represent medical safety findings in project and client meetings; support audits and inspections.
• Act as Lead Safety Physician or senior backup on assigned projects, providing escalation support when required.
• Mentor junior medical and safety team members and support training, transitions and knowledge sharing.
• Ensure quality, compliance and timely delivery of medical safety services while maintaining awareness of evolving regulatory requirements.

Required profile

• Medical degree (MD) – required.
• Minimum 3 years of clinical practice experience post‑degree.
• At least 2 years of experience in the pharmaceutical industry, CRO or pharmacovigilance environment preferred.
• Strong scientific judgment, communication and stakeholder management skills.
• Advanced proficiency in English.

Required skills

• Pharmacovigilance processes and regulations (ICSRs, aggregate safety reports).
• Good Clinical Practice (GCP) and ICH guideline knowledge.
• Experience with safety databases and signal detection tools.
• Advanced English language proficiency.