Rachana Khairnar

Drug Safety Associate @Tata Consultancy Services

Mumbai, IN

PV case processorExperienced in management of individual case safety report (ICSR) of all case type (spontaneous, Clinical studies and solicited programs) that includes:Registration (Data entry) Of ICSRs in the Argus safety database.Conducting duplicate searches prior to registration and identifying potential duplicates.Responsible for full review and data entry of Individual Case Safety information (ICSR) in the safety database.Review adverse event (AE) report data for completeness and verify certain fields to determineInitiate follow-up activities to obtain additional information and clarification, as appropriate.Responsible for coding all medical history, events, drugs/procedures/indications and Lab. Tests according to the appropriate dictionary (Ex: MedDRA, Company product dictionary and WHO-DD).