Passionate pharmacovigilance professional (Senior drug safety associate) with a 6+ years of experience, dedicated to enhancing safety processes for patient welfare and regulatory compliance. Exprienced in health care industry. Strong problem-solving, strategic thinking, and communication skills. Adept at case management, quality management, and regulatory submissions. Proven track record of team training and leadership. Committed to continuous process improvement and results delivery. Experienced in:PharmacovigilanceClinical MonitoringGood Clinical Practice (GCP)Clinical Trial Management System (CTMS)Drug Drug developmentQPPV oversightCase managementPV complianceSOP developmentQuality assuranceGlobal regulatory compliance. Expertise in database management, including:ArgusMedDRAIRMSCITRIXPRIMA ReportumMain duties included:Well versed with review of literature articles, quality review of cases.case processing from book in, data entry quality review, all adverse event pulling, coding of all events (by MedDRA) and drugs (by CPD or WHO DD), including data entry, labelling (USPI and CCDS), approval numbers, manual coding (by MedDRA), narrative writing, annual ANDA reports, complaince report, reconciliation, mentoring, training of new joiners.Also a certified Post Graduate in Drug Regulatory Affairs.