Shashikanth Bochula

• Process adverse event reports received from sites/reporters. • Perform QC review of completed individual and periodic safety reports. • Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information. • Ensure case files are compliant with SOPs.

• Transcribe cases, write narratives and perform medical coding of the data using CDD, WHODD and MedDRA. • Quality check of narratives. • Processed 2000 plus serious cases and more than 5000 non-serious cases (ICSR’s). • Lead a team of 8 members for one of our client’s DSU (drug safety units)