Product Safety Lead (Pharma)

About the role

The Product Safety Lead (PSL) will own the safety strategy and benefit‑risk decision‑making for assigned pharmaceutical products throughout their lifecycle. Reporting to the client’s safety organization, the PSL acts as the primary subject‑matter expert for pharmacovigilance activities, ensuring proactive risk management and transparent communication with regulators.

Key responsibilities

• Develop and maintain the safety profile of molecules, updating risk‑management plans as new data emerge.
• Lead the preparation and submission of clinical safety reports, aggregate safety narratives, and regulatory dossiers.
• Conduct signal detection, evaluation and assessment, providing timely recommendations to cross‑functional teams.
• Collaborate with medical, regulatory, clinical development and commercial stakeholders to integrate safety considerations into product decisions.
• Represent the client in interactions with health authorities, delivering clear safety updates and responding to queries.

Required profile

• Advanced scientific or medical degree (e.g., PharmD, MD, PhD) with strong background in pharmacovigilance.
• Proven experience in end‑to‑end safety data management for pharmaceutical products.
• Excellent analytical and critical‑thinking abilities, with a track record of influencing matrixed teams.
• Strong communication skills for presenting safety information to internal and external audiences.

Required skills

• Pharmacovigilance (PV) processes
• Signal detection and assessment
• Regulatory submission preparation
• Clinical safety reporting