Senior Manager, Aggregate Reporting Management

Regeneron Pharmaceuticals

Job Location:

Warren, OH - USA

Monthly Salary: $ 134400 - 219200

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Regenerons 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:

Bachelors degree required (advanced degree or HCPfocused 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.

#GDPSJobs

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

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 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 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)

$134400.00 - $219200.00

Required Experience:

Senior Manager

Regenerons 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 ph...