Senior Manager, Aggregate Reporting Management

Regeneron's Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team!

In this role, a typical day might 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.

This role might be for you if you can/have:

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.

To be considered for this opportunity, you must have the following:

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.

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Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€86,800.00 - €141,200.00