Technical Lead and Lead Analyst IT professional with over 17 years’ experience in Pharmaceutical industry particularly in the field of Pharmacovigilance with expertise in data processing, migration and management of Drug Safety, Adverse Events Data collection and reporting, and Risk Management systems (Oracle ARGUS, Oracle AERS, E-TRACE, Thesaurus Management System (TMS)) for reporting and evaluating suspected adverse reactions during clinical trials and post marketing authorizations of medicinal products. Possess strong in-depth knowledge of E2B Electronic Data Submission process, aggregate reporting, and Adverse Reactions case processing workflow lifecycle. Experienced in AE data migration between different AE reporting systems using manual and automated processes. Strong hands on development skills in Oracle, PL/SQL and XML. Extensive knowledge in MedDRA dictionary structure and semi-annual versioning update process. Experience includes strong understanding of FDA’s Good Documentation and Quality Assurance Practices, GxP and 21 CFR Part 11 requirements for validated systems. Strong analytical and problem-solving skills. Developed a reputation of being a dedicated and resourceful team player with tenacious work ethic.Oracle PL/SQL, SQL, XML, ARGUS, E-TRACE, Oracle AERS, TruMigrate, TruCompare, TruConsole, Thesaurus Management System (TMS) and TMS Light Browser, MedDRA, REMEDY 7 Incident and Change Management system, GNOSIS document management system, Oracle Forms/Reports, MS Office, MS Project, MS Access, SQL Developer, SQL Navigator, TOAD for Oracle