Manager, ICSR Processes and Systems

About This Role The Manager, ICSR Processes and Systems is accountable for providing ICSR processing subject matter expertise and ensure compliance of global PV regulations and ICH standards of ICSR handling within our  technology systems, (e.g., safety database) used by Global Case Management.What You’ll Do Review and assess regulatory requirements pertaining to ICSRs and ensure Biogen ICSR procedures efficiently meet regulatory compliance and also in alignment with industry standard practices.Review contents of GSD releases and perform impact assessment to Biogen ICSR procedures and execute on identified impacts (e.g. procedural document updates, training material updates, etc.)Ensure effective change management, knowledge transfer, and training of GSD releases to internal and external usersContribute to system testing through UAT review and executionCollaborate with other PV functions on developing, using, and maintaining GxP and non-GxP systems used by GCM for ICSR handling and oversightSupport global regulatory PV inspections and auditsWho You AreYou have a demonstratable knowledge of GVP regulations and ability to implement these requirements in processes, procedures and systems. You are adaptable, accountable, self driven, and able  to manage competing priorities, with key strengths in communication, critical thinking, and problem solving.