Nitish Chugh Email & Phone Number

I have completed a Master's in Pharmacy. Moreover, I am skilled in Pharmacovigilance ICSR processing and management.My skills include-》Practical hands-on assessment of case reports (ICSRs) for seriousness, expectedness, causality, and other case processing points.》Well versed with pharmacovigilance concepts (MedDRA coding and WHO-Drug Dictionary coding) and pharmacovigilance guidelines (ICH, GVP, CIOMS, sch. Y).》Knowledge of case triage, case narrative writing, causality determination, signal management process, etc.》Understanding of drug development process including drug safety and different phases of clinical trials.》Basic understanding of regulatory requirements for clinical research and pharmacovigilance.》Well versed with regulatory reporting concepts for PSUR, PBRER, DSUR, etc.