Senior Manager, Aggregate Reporting Management

Job description

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...