Divya Kasi

Background

About Divya Kasi

TRIAGE AND ICSRS • Triaging of the cases received for company by various sources and providing initial assessment, seriousness, causality and expectedness or listedness of adverse events. • Quality check and medical review of ICSRs to ensure accurate and consistent Argus data entry from source documents. • Ensure scientific rigor through accurate, complete and consistent processing of adverse event reports from source documents with emphasis on timelines and quality. • Ensure the accurate selection of adverse events from source documents and usage of medical dictionaries (MedDRA) for coding of events and guidance to code medical history, drugs and adverse event terms. • Complete medical assessment of safety cases and provide overall medical assessment comment. • Planning, organizing, and managing daily work within team to meet service level timelines and deliverables. AGGREGATE REPORTING • Preparation of sections of medical significance/inputs and narratives for the scheduled Periodic/Annual Reports (FDA) focusing on the stipulated preferred terms. • Responsible for the medical input and assessment, signal information, and conclusion section of the Aggregate Safety Reports (PADERs) • Knowledge on PADERs/PSURs/ PBRERs in accordance to respective guidelines. TRAINING • Certified Trainer for pharmacovigilance activities.