Director of Global Patient Safety and Science

3 weeks ago


Uxbridge, United Kingdom Regeneron Full time
Job Summary

The Associate Director, Safety Scientist in Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead.

Key Responsibilities
  • Signal Detection and Evaluation: Complete signal detection activities in line with approved safety surveillance plans, perform signal evaluation for identified signals, and author safety evaluation reports.
  • Safety Document Management: Manage preparation and review of safety documents, including DSUR, PSUR, RMP, and responses to health authority queries.
  • Presentations and Team Collaboration: Prepare and deliver presentations at Signal Management Team (SMT) meetings, participate in clinical study team meetings for assigned compounds, and represent GPS on cross-functional teams.
  • Process Improvement: Actively participate in process improvement initiatives, such as developing and maintaining relevant SOPs, WIs, and supporting documents.
Requirements
  • Education and Experience: Master's, PhD, or PharmD (preferred) with 10+ years of relevant safety-related experience in the pharmaceutical/biotech industry or health authority.
  • Skills and Abilities: Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments, work with a safety system database, prioritize and multitask to meet deliverables, and effectively communicate safety findings.


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