Global Patient Safety Lead
4 weeks ago
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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