Regeneron’s Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team!
In This Role
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. The role supports the preparation, distribution and submission of periodic and ad‑hoc safety reports to health authorities, collaborators and contract research organizations worldwide in a compliant and scientifically robust manner.
- Drive preparation, development and maintenance of aggregate reporting deliverables (PSURs/PBRERs, PAER, DSURs, local periodic reports, SUSARs).
- Lead aggregate report planning, production and distribution activities across GPS and other functions in the US, EU, Japan and other ICH and 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 timely, high‑quality aggregate reports and other deliverables.
- Develop and oversee functional specifications for 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 subject matter expert during audits and inspections.
- Oversee and train CRO activities to ensure high‑quality, timely aggregate reports.
- Manage vendor relationships to achieve high‑quality outputs.
- 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).
- 5+ years of pharmacovigilance experience with a focus on aggregate safety reporting.
- Project management experience strongly preferred; PMP certification preferred.
- Experience with health authority inspections (PV and GCP).
- Medical writing experience with regulatory documentation.
- Strong project management, strategic decision‑making and analytical skills.
- Excellent communication and writing skills.
- Strong understanding of scientific content.
- Proven experience with technology implementations that streamline process execution.
Regeneron offers a competitive and comprehensive total rewards package that includes annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off and family support benefits.
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 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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