Snehal Gaykar

Pharmacovigilance expert with 11 years of end-to-end PV experience including 4.5 years in managerial 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 • Evaluation of Adverse Events • Safety Data Exchange Agreement • Pharmacovigilance System Master File • Embase literature search • Stakeholder management Represented company in various regulatory authority inspections including MHRA, BfArM, USFDA, Health Canada, TGA to name a few.