Senior Manager, Aggregate Reporting Management

Job Overview Regeneron's Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team! A typical day may include: 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 Drive preparation, development and maintenance of aggregate reporting (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs). Deliverables Lead 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. Provide expertise and guidance to authors and contributors of aggregate reports. Maintain compliance metrics and contribute to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non‑compliance. Implement effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality. Develop and oversee functional specifications of data requirements for aggregate deliverables from the safety and clinical databases. Collaborate with Global Patient Safety (GPS) and other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports. Act as a subject‑matter expert during audits and inspections. Provide oversight and training as needed of CRO activities in support of high‑quality and timely aggregate reports. Act as a functional vendor manager overseeing and driving high‑quality outputs from vendors. Develop and maintain aggregate report procedural package (SOPs, Work Instructions), reports' templates, KPIs. Drive 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, strategic decision‑making, analytical, communication and writing skills. Strong understanding of scientific content. Proven experience with technology implementations allowing for streamlined process execution. Benefits 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 leave (military and parental leave) for eligible employees at all levels. Salary Range (annually) $134,400.00 - $219,200.00. EQUAL OPPORTUNITY EMPLOYER 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. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)