Director, Safety Physician

Summit Therapeutics, Inc.

🇬🇧 English

Job description

About the role

Summit Therapeutics is seeking a Director, Safety Physician to lead pharmacovigilance activities for both investigational and marketed oncology products. Reporting to the VP of Patient Safety & Pharmacovigilance, the role ensures patient safety across global clinical studies.

Key responsibilities

Perform medical review of individual case safety reports (ICSRs), including narratives, coding, expectedness, causality and seriousness.
Evaluate the medical accuracy of ICSR reports and ensure high‑quality submissions.
Prepare Analyses of Similar Events (AOSE) for IND safety reporting.
Confirm criteria and content for expedited reporting and unblinding (e.g., SUSARs, urgent safety issues).
Lead or contribute to safety information presentations for the Drug Safety Committee, Product Safety Review Team and Independent Data Monitoring Committee.
Provide strategic input for adverse event monitoring, signal detection and global pharmacovigilance regulatory compliance.
Safeguard patients enrolled in clinical trials or receiving Summit products.

Required profile

Required skills

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