Job Description
**Senior Manager of Global Patient Safety** 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. **Key Responsibilities:** • Perform signal evaluation for identified signals and author safety evaluation reports and Health Hazard Reports • Run the preparation and review of aggregate safety documents, including DSUR, PSUR, RMP, IB, and responses to health authority queries • Prepare and deliver presentations at Signal Management Team (SMT) meetings • Participate in clinical study team meetings for assigned compounds • Own the day-to-day operations and directly contribute to the efficient functioning of the Safety Sciences team for assigned compounds • Actively participate in process improvement initiatives, such as the development and maintenance of relevant SOPs, WIs, and supporting documents **Requirements:** • Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments • Strong technical and problem-solving skills/experience • Excellent organizational and relationship leadership skills • Ability to build and strengthen collaborative partnerships internally and externally • Proactive and self-disciplined, meet deliverables, and effectively use your time and prioritize **Ideal Candidate:** • Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8 years of industry or relevant clinical experience • Master's, Ph.D., or Pharm D. degree • Ability to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC) and other teams with members external to Regeneron **About Regeneron:** 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. **Benefits:** • Comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.