Senior Manager, Global Patient Safety - General Medicine
Build our future together: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, NJ4 days per week on siteDiscover your role:Complete signal detection activities in line with approved safety surveillance planPerform signal evaluation for any identified signals and author the safety evaluation reportsManage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queriesPrepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compoundsParticipate in other risk management activities as appropriate for assigned compoundsWe 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 RegeneronActively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documentsThis role requires:Minimum a Master's, PhD, or PharmDOffers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authorityAbility to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environmentsAbility to work with a safety system database for purposes of medical case review and simple queriesAble to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritizeAbility to effectively communicate (verbal and written) safety findings#GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veter...