Snehal Gaykar

Background

About Snehal Gaykar

Exploring AI in Pharmacovigilance. A Pharmacovigilance expert (small molecule, biosimilar, devices) with 14 years of end-to-end PV experience including 5 years in line manager capacity. • Signal detection • Periodic Benefit-Risk Evaluation Reports (PBRER/ PSUR)/ Development Safety Update Reports (DSUR) • Argus line listing, configurations, OBIEE reports • Periodic Adverse Drug Eexperience Reports (PADER) • Risk management Plan and effectiveness check • Literature abstracts and Case Narratives • Addendum to Clinical Overviews, Benefit Risk Profile • Medical Dictionary for Drug Regulatory Activities (MedDRA) • Management of ICSRs and Evaluation of Adverse Events • Safety Data Exchange Agreement • Pharmacovigilance System Master File • Embase literature search (Emtree) • Project management • Hiring PV Subject Matter Experts for Canada Represented company in numerous regulatory authority inspections including MHRA, BfArM, USFDA, Austria, Swiss Medic, Health Canada, TGA, Belgium, Slovenia, Poland, Bulgaria, Kazakhstan, etc.