Regeneron’s Patient Safety organization seeks a Senior Manager, Aggregate Reporting Management to oversee global aggregate safety reporting activities across the product lifecycle.
Responsibilities
- Drive preparation, development and maintenance of aggregate reporting documents (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs)
- Lead aggregate report planning, production and distribution activities across GPS and other functions in the US, EU, Japan, other ICH regions, and non‑ICH regions
- Provide expertise and guidance to authors and contributors of aggregate reports
- Maintain compliance metrics and contribute to the implementation of Quality Events and CAPA for non‑compliance
- Implement effective structures, procedures and tools to ensure aggregate reports and other functional deliverables are completed on time and with high quality
- Develop and oversee functional specifications of data requirements for aggregate deliverables from safety and clinical databases
- Collaborate with GPS and other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) to contribute to aggregate safety reports
- Act as a subject‑matter expert during audits and inspections
- Provide oversight and training for CRO activities to support high‑quality and timely aggregate reports
- Manage vendor relationships, ensuring high‑quality outputs from external vendors
- Develop and maintain aggregate report procedural packages (SOPs, Work Instructions), report templates, and KPIs
- Drive process improvement through automation and other technology initiatives
Qualifications
- Bachelor’s degree required (advanced degree or HCP‑focused background preferred) and 5+ years of pharmacovigilance experience with a focus on aggregate safety reporting
- Strong project‑management experience; PMP certification preferred
- Experience with health‑authority inspections (PV and GCP)
- Medical‑writing experience with regulatory documentation
- Excellent strategic decision‑making and analytical skills
- Strong communication and writing skills
- Deep understanding of scientific content
- Proven experience with technology implementations that streamline process execution
Benefits
- Competitive total‑rewards package including annual bonuses, equity awards, pension/retirement benefits, and 401(k) company match
- Health and wellness programs, fitness centers, and comprehensive insurance benefits (medical, dental, vision, life, and disability)
- Paid time off and family support benefits
- Benefits may vary by country and role; further information provided during the recruitment process
Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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 veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
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