Senior Manager of Global Patient Safety

6 days ago


Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time
Job Summary

We are seeking a Senior Manager of Global Patient Safety to play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Ophthalmology Therapeutic Area. This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.

Key Responsibilities
  1. Perform signal evaluation for identified signals and author the safety evaluation reports and Health Hazard Reports.
  2. Run the preparation and review of aggregate safety documents including DSUR, PSUR, RMP, IB, responses to health authority queries and queries from other departments.
  3. Own the day-to-day operations and directly contribute to the efficient functioning of the Safety Sciences team for assigned compounds.
Requirements
  1. You have the ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.

To be considered for this opportunity, you must have previous safety or relevant clinical experience in the pharmaceutical industry, typically with at least 8 years of industry or relevant clinical experience in pharmaceutical/biotech industry or health authority. The ideal candidate must possess a Master's, PhD, or PharmD.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.



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