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Senior Manager, Aggregate Reporting Management
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Senior Manager, Aggregate Reporting Management
Senior Manager, Aggregate Reporting Management - Regeneron’s Patient Safety Organization
About the Role
Regeneron’s Patient Safety Organization is seeking a Senior Manager, Aggregate Reporting Management to join our team.
In this role within Global Patient Safety (GPS) Operations, you will be responsible for managing aggregate safety reporting activities across all phases of the product lifecycle. The position 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.
Typical Responsibilities
- Drives the preparation, development, and maintenance of Aggregate Reporting Deliverables (e.g., PSURs/PBRER, PAERs, DSURs, Local Periodic Reports, SUSARs)
- Leads Aggregate Report planning, production, and distribution activities across GPS and other functions in US, EU, Japan, ICH regions, and non-ICH regions
- Provides expertise and guidance to authors and contributors while ensuring the scientific robustness and compliance of aggregate reports
- Oversees compliance metrics and contributes to Quality Event and Corrective Action and Preventive Action (CAPA) processes for non-compliance
- Designs and implements effective structures, procedures, and tools to drive the timely and high-quality completion of functional deliverables
- Develops and oversees functional specifications for data requirements for aggregate reporting from safety and clinical databases
- Collaborates with Global Patient Safety, Epidemiology, Clinical Development, Regulatory Affairs, Statistics, and other areas on aggregate safety reports
- Acts as a Subject Matter Expert (SME) during health authority audits and inspections
- Provides oversight and training for contractor organizations (CROs) to ensure high-quality and timely aggregate reports
- Oversees vendor management of external partners to drive quality outputs
- Develops and maintains aggregate report procedural documentation (e.g., SOPs, Work Instructions, templates, and KPIs)
- Drives process improvement through automation and technology initiatives
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Requirements
To apply, you must possess:
- Bachelor’s degree (advanced degree or Healthcare Professional (HCP) background preferred)
- 5+ years of Pharmacovigilance experience, with a demonstrated focus on Aggregate Safety Reporting
- Project management experience (translated to comparative Project Management Professional, PMP, preferred)
- Experience with health authority inspections, including Pharmacovigilance (PV) and Good Clinical Practice (GCP)
- Strong medical writing experience with regulatory documentation
- Excellent project management, strategic decision-making, and analytical skills
- Exceptional communication and writing abilities
- Proven track record with technology implementations to streamline process execution
Ideal Candidate Qualities
The right candidate will:
✔ Lead and strategically develop Aggregate Reporting programs ✔ Foster cross-functional collaboration with diverse teams to achieve high-impact results ✔ Maintain strong compliance and quality governance expertise ✔ Adapt to ever-evolving regulatory expectations and emerging pharmacovigilance best practices ✔ Activate process improvements to increase efficiency, transparency, and data-driven decision-making
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Equality & Inclusion
Regeneron is committed to building an inclusive culture. We actively welcome and consider applications from all qualified candidates without regard to:
- Race
- Color
- Religion or belief (or lack thereof)
- Sex, gender identity, or expression
- Sexual orientation
- Marital/civil partnership status
- Age
- Disability
- Nationality or citizenship Familial status Genetic information Veteran or military status
We provide reasonable accommodation to applicants with known disabilities or chronic illnesses (where legally required), ensuring fair consideration.
Benefits Overview
We offer a competitive total rewards package, which may include:
- Performance-based bonuses
- Equity grants
- Pension/retirement contributions
- Health and wellness initiatives including fitness centers
- Insurance benefits (medical, dental, vision, life, and disability)
- Paid time off and family support benefits
For U.S. role details, visit Regeneron Benefits. For other regions, benefits specifics will be provided during recruitment.
Note: Many roles require onsite work. Clarifications on location expectations can be discussed with the interviewer.
Ready to join Regeneron’s innovative team and advance the science of medicine?
Explore careers opportunities on: Regeneron Careers
Apply now to live the Regeneron Way!
Background checks may be conducted for roles. Disaiplayed compensation ranges are inclusive of hourly, salaried, and contractual positions.
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