Senior Manager, Aggregate Reporting Management

Overview Regeneron's Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team! Typical Day This position in the Global Patient Safety (GPS) Operations is responsible for management of aggregate safety reporting activities across all phases of the product lifecycle. This role supports the consistent, compliant, and scientifically robust preparation, distribution and submission of periodic and ad-hoc safety reports to health authorities, collaborators and contract research organizations worldwide. Responsibilities Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions Provides expertise and guidance to authors and contributors of aggregate reports Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports Acts as subject matter expert during audits and inspection. Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports Acts as a functional vendor management overseeing and driving high quality outputs from our vendors Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports’ templates, KPIs Drives process improvement through automation and other tech initiatives. Qualifications Bachelor’s degree required (advanced degree or HCP‑focused background preferred) and 5+ years of Pharmacovigilance experience, with a demonstrated focus on Aggregate Safety Reporting. Project management experience strongly preferred, PMP preferred Experience with health authority inspections (PV and GCP) Medical writing experience with regulatory documentation Strong project management skills Excellent strategic decision-making and analytical skills Strong communication and writing skills Strong understanding of Scientific content Proven experience with technology implementations allowing for streamlined process execution. Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries’ specific benefits, please speak to your recruiter. EEO Statement 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. Salary Range (annually) $134,400.00 - $219,200.00 #J-18808-Ljbffr