Sumit Verma

WORK HISTORY

EDUCATION

ABOUT SUMIT VERMA

I’m a post graduate in Pharmacovigilance and Clinical Research with passion to start my career in Pharmacovigilance and available as immediate joiner for Drug Safety Associate role. I am fully equipped with relevant skills for the job of Drug Safety Associate and ability to work independently but guided by documented procedures, with appropriate support. My 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 guidelinesHands 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 timelinesHands on knowledge about safety database ICSR processing with defined WORKFLOW including Duplicacy check, case Book-In, complete case entry Good knowledge to perform MedDRA coding for medical history, events, drugs /procedures/indications and laboratory tests in ICSRsExposure to Global Pharmacovigilance activities and standards including ICH, GVP, 21 CFR, CIOMS etc. 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 activitiesExposure to Audits/Inspections along with Quality Management System In addition, I have excellent attention to details ability work effectively as part of a team and once given the opportunity will be a valuable asset to the organization.