Global Patient Safety Lead - Signals & Risk

Regeneron Pharmaceuticals, Inc.; Uxbridge; Sur place; GBP 70 000 - 110 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team in the UK. You will lead signal detection/evaluation activities and contribute to safety documentation across clinical development and post-marketing environments.

Role includes presenting at SMT meetings, collaborating with RSOC/IDMC and cross-functional teams to ensure rigorous safety interpretation and benefit-risk assessment.

Qualifications

• Minimum Master degree, PharmD or PhD.
• 5+ years of risk management or relevant clinical experience in pharma/biotech or health authority.
• Experience applying FDA, EU and ICH guidelines governing pharmacovigilance.

Responsabilités

• Complete signal detection activities in line with the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation/review of DSUR, PSUR, RMP, and regulatory responses.
• Prepare and present at Signal Management Team (SMT) meetings; support clinical study teams.

Connaissances

Pharmacovigilance

FDA/EU/ICH guidelines

Data analysis

Cross-functional collaboration

Project management

Safety surveillance

Communication

Formation

Master's Degree

PharmD

PhD

Outils

Excel

Description du poste

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team in the UK. You will lead signal detection/evaluation activities and contribute to safety documentation across clinical development and post-marketing environments.

Role includes presenting at SMT meetings, collaborating with RSOC/IDMC and cross-functional teams to ensure rigorous safety interpretation and benefit-risk assessment.