Duration: 12 months with possible extension
The contract Global Safety Officer (GSO) with work with the TAH to provide safety oversight for assigned products. The contract GSO leads the Safety Analysis Team (SAT) and Global Safety Team (GST) with input from the TAH.
Applicable tasks may vary by product(s) assigned. Medically relevant activities requiring input can be delegated to the contract Global Safety Physician while remaining accountable for the activities (e.g. validate a signal).
Product safety profile, benefit-risk evaluation, and risk communication:
- Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS])
- Identify relevant data and conduct benefit-risk evaluation
- Participate in product label process