Profile: 19+ years of experience in Clinical research and Pharmacovigilance operations; possesses Masters in Pharmaceutical Operations and Management. Expert Areas areas are Clinical Research, Pharmacovigilance (PV), Quality Assurance (QA), Regulatory Compliance, Safety Database Implementation. Attaining expertise in drug discovery and drug safety utilizing 19+ years of experience in clinical research and pharmacovigilance arenas. Established departments like ‘Clinical Compliance’ and “Global Pharmacovigilance” from scratch to hatch level. Centralized Pharmacovigilance operations and integrated local PV functions with global operations. Ameliorated PV systems (Human Pharmacovigilance) at 3 USbased companies and a Germany based company (Veterinary Pharmacovigilance). As a qualified internal auditor, conducted several customers, affiliate, vendor and internal audits of Clinical and Pharmacovigilance systems across locations. (5) USFDA, (4) ANSM, (3) AEMPS, (2) EUQPPV, (1) MHRA, (1) ANVISA and (1) MCC audits of Pharmacovigilance systems with no critical observations. Saved more than $ 500,000 by implementing a tool to validate R3 XMLs downloaded from EudraVigilance without exporting them into the safety database. Implemented safety databases like Oracle AERS, PvNet, Oracle Argus, PV247 and other toolslike Emperica Signal Topics, Axway Synchrony Gateway Submission. Played pivotal role in several Mergers and Acquisitions. Data Migration from one safety database to other. International Exposure in Brazil • Canada • China • France • Germany • Mexico • Spain • United States of America. Languages Known: Hindi, English and Gujrati. Based in Ahmedabad, Gujarat.