Anisha M.

Managed and entered safety data into adverse event tracking systems with high precision. Wrote patient narratives and applied MedDRA coding for adverse event classification. Evaluated adverse events against product labels to assess listedness status. Generated queries to acquire additional or clarifying information from medical teams. Submitted expedited Serious Adverse Event (SAE) reports to clients, regulators, ethics committees, and investigators within set deadlines. Reviewed adverse event data for accuracy and adherence to regulatory standards. Supported the preparation and submission of periodic safety reports to global regulatory agencies. Ensured consistency and data integrity across safety databases through reconciliation practices. Organized safety documentation, assisting in the archival of case and project-related files. Drafted compliant safety documents, including ICSR narratives, expedited SAE reports, and periodic safety reports (PSUR/DSUR) following ICH, E2B, GVP, and global regulatory guidelines.