What are the responsibilities and job description for the Patient Safety Leader position at Regeneron Pharmaceuticals?
As a key member of the Global Patient Safety team, you will play a crucial role in developing and implementing safety strategies for molecules in clinical development and post-marketing phases within designated Therapeutic Areas. Your primary responsibility will be to aggregate, review, and analyze safety data to support informed safety interpretation and benefit-risk assessment.
You will oversee signal detection activities according to approved safety surveillance plans and evaluate identified signals. Additionally, you will prepare and review critical safety documents, including DSUR, PSUR, RMP, and responses to health authority queries. Effective communication (verbal and written) of safety findings is essential for success in this role.
Furthermore, you may represent the Global Patient Safety team on cross-functional teams, including Regeneron's Safety Oversight Committee and Independent Data Monitoring Committees. You will also contribute to process improvement initiatives by developing and maintaining relevant SOPs, WIs, and supporting documents.
Key Skills:
- Apply FDA, EU, and ICH guidelines governing pharmacovigilance activities in both clinical trial and post-marketing environments
- Work with safety system databases for medical case review and simple queries
- Exercise proactive self-discipline, meeting deliverables and effectively managing time and priorities
- Effectively communicate (verbal and written) safety findings
