Global Patient Safety Lead

4 weeks ago


Uxbridge, United Kingdom Regeneron Full time

Job Summary

The Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position requires a strong understanding of pharmacovigilance activities and the ability to apply relevant FDA, EU, and ICH guidelines.

Key Responsibilities

  • Complete signal detection activities in line with approved safety surveillance plans
  • Perform signal evaluation for identified signals and author safety evaluation reports
  • Manage preparation and review of safety documents, including DSUR, PSUR, RMP, and responses to health authority queries
  • Prepare and deliver presentations at Signal Management Team meetings and participate in clinical study team meetings for assigned compounds
  • Participate in risk management activities and represent Global Patient Safety on cross-functional teams
  • Actively participate in process improvement initiatives, including the development and maintenance of relevant SOPs, WIs, and supporting documents

Requirements

  • Master's, PhD, or PharmD degree
  • 8+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority

Company Overview

Regeneron is a leading biotechnology company dedicated to discovering and developing innovative medicines for serious diseases. We are committed to advancing science and improving human lives.



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