Working as Business Quality Assurance team memberPrepare, review, control and maintain SOPs, SWIs, QCP, role descriptions and other projectspecific documents Performing monthly process audits across all the Affiliate activities, ensuring overall process quality and identifying any deviationSupporting internal/ external audits/regulatory InspectionsTracking audit/inspection requests and findings to ensure timely closureMonitor/ review / tracking RCA/CAPAs and ensuring timely closureThorough knowledge on General Data Protection RegulationUK/IRE Affiliate PV VendorPerforming Info Receipt activity for UK/IRE Affiliate countries using MY ICSR/Trilogy databaseHandling AE/PQC/MI case reports from vendors and performing QC for cases processedReviewing/sending/tracking follow-up query letters for individual casesPerforming Source Data Verification reconciliation activity periodically with VendorsCase Processing ActivityPerforming data entry for post-marketing, legal, regulatory cases using ARISg safety databasesMedical coding of Adverse Events using MedDRA and Product coding using WHO dictionary and Company product dictionaryAssessing all Adverse Events for Expectedness/ ListednessWriting Safety Narrative for the casesSME for NQ activity

Thorough knowledge on ARGUS safety databases for documentation and reporting of Adverse EventsPerforming PADER Submission through FDA Web traderThorough knowledge Aggregate reporting and Signal detectionCreating Change Control Form (CCF) for family, product, license, destination and study configuration inARGUS safety databases, QC of CCF’s and getting it approved from ClientsPerforming data entry for post-marketed, legal, regulatory and Literature cases.To identify PV receipt date (day 0) and valid caseMedical coding of Adverse Events using MedDRA.Assessing all Adverse Events for Expectedness/ Listedness as per the Company Core Data Sheet/ Company Core Safety Profile.Writing Safety Narrative for serious and non-serious cases.