Key Responsibilities:
1.Scientific/Medical Knowledge PV Expertise:
Responsible for signal detection and evaluation activities for assigned products.
Ensures that accurate and fit-for-purpose evaluation documents with clear 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 GCSP.
Completes any post audit/inspection activities within the required timeline
Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/p...