Principal Physician, Patient Safety

About the role

The Principal Physician, Patient Safety will provide senior medical oversight for pharmacovigilance activities across global drug development and post‑marketing programs. This role ensures that patient safety is embedded throughout the product lifecycle and influences regulatory decisions.

Key responsibilities

• Lead medical review of adverse events, case narratives, and safety signals.
• Interpret clinical and safety data from trials, real‑world sources, and literature.
• Prepare and medically review regulatory safety documents (PBRER, PSUR, DSUR, HHE, signal reports).
• Ensure accurate medical coding, causality assessment, and compliance with ICH GCP, GVP and internal SOPs.
• Drive signal detection, validation, and ongoing safety monitoring for assigned products.
• Provide medical input for risk management plans and regulatory submissions.
• Act as subject‑matter expert during audits, inspections, and regulator interactions.
• Collaborate with data management, clinical, regulatory and safety operations teams.
• Mentor junior physicians and support capability‑building initiatives.
• Participate in therapeutic area discussions and continuous process improvement.

Required profile

• Medical degree (MBBS, MD or equivalent) with completed clinical training.
• Extensive experience in clinical medicine, pharmacovigilance, drug safety or clinical research.
• Strong knowledge of drug safety principles, adverse event reporting and global regulatory frameworks (ICH GCP, GVP).
• Proven experience in medical review of safety cases from clinical trials and post‑marketing data.
• Ability to assess benefit‑risk profiles and provide sound medical judgment.
• Excellent communication skills.

Required skills

What we offer

• Opportunity to influence patient safety at a global scale.
• Leadership role with strategic decision‑making impact.
• Collaboration with cross‑functional and international teams.