Responsibilities

The Senior Safety Scientist will support signal detection, evaluation, and management through aggregate data analysis and case-level reviews, creating presentations for assigned programs or studies. They will assist in developing risk management strategies for both pre- and post-marketed programs, including contributing to RMPs, evaluating risk minimization activities, and responding to regulatory safety requests. The role involves reviewing adverse events/serious adverse events from clinical trials, providing input on TFLs, listings, and biometrics outputs, and leading the preparation of periodic safety reports (DSUR, PSUR, PBRER) in accordance with regulatory requirements. Furthermore, the Senior Safety Scientist will support safety governance activities, conduct literature reviews, contribute to regulatory filings (CSRs, IBs, labeling), support inspection preparedness, and stay updated on regulatory changes and SOPs.