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Medical Safety Expert
1 week ago
- Lead the detection and analysis of signals, including strategy, frequency, and timing, and raise potential signals for team discussion.
- Conduct medical reviews and contribute to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, and other regulatory submissions.
- Provide safety oversight and contribute to label development, review, and updates, as well as the Integrated Safety Summary or Common Technical Document.
You will also perform medical reviews and clarifications of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs).
