Job Description
This position supports the Safety Operations organization to achieve its mission of improving patient lives by delivering high quality, and timely adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at AbbVie. The Manager, Office of Safety Operations sits in the ICSR Compliance department within the Safety Operations function and is responsible for monitoring and ensuring compliance with the global regulatory reporting of ICSRs.
The role includes management of investigations to address compliance deviations and drive continuous improvement, as well as managing license partners to ensure alignment on reporting obligations and safety data exchange requirements. The successful candidate will also support internal and external audits and regulatory inspections by leading in the front room, providing documentation, data analysis, and subject matter expertise related to ICSR processes.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.