Navneet Kaur

WORK HISTORY

EDUCATION

ABOUT NAVNEET KAUR

Master of Pharmacy in PharmacologyMy professional skills in Pharmacovigilance are:•Performing the review and evaluations of ICSR information for validity, seriousness, expectedness and causality assessment following standard Pharmacovigilance procedures and guidelines.•Hands on experience in writing safety narratives for ICSRS from different sources like spontaneous, literature, etc. •Hands on experience in processing 60+ ICSRS meeting the quality standards and timelines.•Hands on knowledge about safety database ICSR processing with defined workflow including duplicate check, case book-in, complete case entry.•Good knowledge to perform MedDRA coding for medical history, events, drugs, procedures, indications and laboratory tests in ICSRs.Exposure to Global Pharmacovigilance activities and standards including ICH, GVP,•21 CFR, CIOMS for developmental and/or marketed products. Exposure to aggregate reporting in Pharmacovigilance including PSUR/PBRER,•PADER, DSUR including processes, timelines and standards as per EU, US, etc.Exposure to signal generation and safety analysis activities•Exposure to Audits/Inspections along with Quality Management System.In addition, I\'m very detail oriented and work effectively as part of a team.