- Responsible for signal detection and evaluation activities for assigned products.
- Ensures that accurate and fit-for-purpose evaluation documents with explicit conclusions are provided in response to internal or regulatory authority requests for safety data.
- Assists in the production of Risk Management Plans (RMPs), Risk Tables for designated products, in consultation with Senior personnel.
- Authors regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
- Acts as a member of a process improvement initiative team within the GCSP.
- Completes any post audit and inspection activities within the required timeline
- Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues or problems and making decisions with consultation of SERM physician.