Senior Drug Safety Specialist

About the role

The Senior Drug Safety Specialist will lead the implementation and management of safety services across pre‑clinical, clinical and post‑marketing projects. Reporting to senior management, the role ensures all safety activities comply with applicable regulations and meet client expectations.

Key responsibilities

• Develop and maintain SOPs, work instructions and associated documentation for safety reporting.
• Assist in budget preparation, proposal reviews and bid defence meetings to grow the safety services portfolio.
• Identify system, process and document requirements to support safety project delivery.
• Implement and improve centralized processes, KPIs and compliance monitoring for safety services.
• Coordinate with sponsors/clients to gather feedback, ensure high‑quality delivery and foster long‑term relationships.
• Prepare and submit regulatory safety documents and manage safety project plans.

Required profile

• Extensive experience in drug safety/pharmacovigilance within clinical research.
• Strong understanding of regulatory guidelines for safety reporting.
• Proven ability to develop SOPs and manage safety projects end‑to‑end.
• Excellent communication skills for client interaction and internal coordination.

Required skills

What we offer

• Opportunity to work with a global leader in clinical trials.
• Collaborative environment with cross‑functional teams.
• Exposure to a diverse portfolio of biotech and pharmaceutical clients.