Nikhil Patil

Process Associate (Pharmacovigivalnce) @Tata Consultancy Services

Pune, IN

Working experience of end-to-end ICSR processing including MedDRA event coding, WHO-DD drug coding, labelling of events, causality assessment, narrative writing, follow-up activity, case corrections and CAPA management process.Handled safety reports from E2B RA, LP, Clinical trial, Regulatory Authority, Post marketing study, Patient-oriented Program, Spontaneous Reports, Medical Device Cases, product quality complaints.Ensuring and closing for all Initial & follow-up cases within the time frame to meet TAT and Regulatory compliance by following SOPs. Good hands-on experience in databases handling with Argus, LSMV and Sapphire safety Database.

Savitribai Phule Pune University

Bachelor of Pharmacy - BPharm

Sinhgad college of arts, commerce & science Pune.

FYJC-SYJC