Krunal Pawar

Narrative writing of events and CIOMS form Determine seriousness criteria Single case assessment and aggregate cases for labeling, causality assessment and seriousness of adverse events SUSAR documentation, processing and analysis Apply medical judgment and knowledge of adverse events during case review Monitoring safety post marketing activities through compliance with SOPs Preparing for regulatory and audit checks Enter and code adverse events using MEDRA,WHODD

Track all adverse event reports for products including medical devices, investigational products and vaccines. Ability to review SAE data for completeness and prepare patient narratives from appropriate documentation Review and assess all source documents, and compile data in an adverse event report Identifying serious adverse events. Perform labeling assessment of adverse events. Monitoring safety post marketing activities

Clinical Epidemiology and Genetic Epidemiology