SeniorManager,GlobalPatientSafety

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Senior Manager** to join our **Patient Safety** team.The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. **When & where:** * Work Location: Tarrytown, NY or Warren, NJ * Hybrid; 4 days per week on site **Discover your role:** * Complete signal detection activities in line with approved safety surveillance plan * Perform signal evaluation for any identified signals and author the safety evaluation reports * Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries * Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds * Participate in other risk management activities as appropriate for assigned compounds * We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron * Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents **This role requires:** ​ * Minimum a Master's, PhD, or PharmD * Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority * Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance acti