Medical Safety Lead

About the role

The Medical Safety Lead is responsible for overseeing the drug surveillance program, ensuring robust risk assessment, and managing safety activities across clinical trials and post‑marketing programs. This role collaborates closely with clinical development teams to provide medical input throughout the product life‑cycle.

Key responsibilities

• Monitor clinical safety data, literature, case reports, and signal detection activities.
• Drive AI‑enabled solutions to streamline pharmacovigilance processes.
• Conduct medical assessments of individual adverse event cases and ensure accurate evaluation.
• Identify, evaluate, and monitor safety signals using single‑case and aggregate data.
• Prepare core safety documents, including clinical overviews and summary reports.
• Support regulatory submissions and respond to safety inquiries from authorities and healthcare professionals.
• Guide adverse event coding, causality assessment, and interpretation of clinical safety data.
• Collaborate cross‑functionally to integrate safety insights across global development teams.

Required profile

• Degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or a medical degree (medical degree required for case safety review).
• Fluency in written and spoken English.
• At least 3 years of experience in drug development, with 2 years in patient safety preferred.
• Experience with clinical trial methodology, regulatory requirements, and scientific publications.
• Strong ability to analyse, interpret, and communicate clinical safety data.

Required skills

• Use of professional AI tools and agents for process improvement.

What we offer

• Hybrid work model (12 days per month in office).
• Opportunity to impact patient safety at scale.
• Collaborative environment within a leading global pharmaceutical company.