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.
Supports safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues an...