Found Description
Principal responsibilities include:
• Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with or as GSL, for assigned product(s).
Accountabilities (primary duties and responsibilities of the job):
• Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT).
• Coordinate and perform signal identification, evaluation and management activities for assigned products.
• Assist with authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses in collaboration with GSL for assigned product(s)
• In collaboration with GSL, work with cros...