Sumit Kumar Email & Phone Number

Business and Application Consultant within Life Sciences domain responsible for Business analysis, Configuration implementation, Customization, Change management and Computer System Validation of Clinical Safety Management Systems (Argus, ARISg and AERS) across various Data Migration and Upgrade projects.Specialties: • Business Process compliance and optimization for Drug Safety and Pharmacovigilance domain• Deep Understanding of, and experience applying/adapting with Life Sciences Regulatory guidelines for ICH, FDA, EMA and PMDA• Exhaustive knowledge of regulatory compliance for 21 CFR Part 11 and GAMP Framework• Exhaustive experience in Application Customization through E2B profile customization (R2 and R3), Post save function, Pre-Save function, Advance Conditions etc.• Keeping tab of new industry jargons like IDMP, GDPR etc.• Deep understanding of Business and System configuration of Argus Safety.• Functional knowledge of Oracle Health Safety Science Suite comprising Argus Safety, Argus Insight, Argus Analytics and Empirica.• Expertise in Computer System Validation activities, following end-to-end V-model under GxP guidelines• Business analysis, Requirement gathering and Fit-Gap Analysis of configuration, Migration and reporting requirements• Project Management activities- Task allocation, Oversight, mid-level track planning and project execution with Zero Defect Delivery• Effective in coaching and training end users to adapt to the new system• Pre-Sales support – providing business and functional inputs for RFP

Listed skills include Argus Safety, Argus Interchange, Pl/Sql, E2B R2 And R3, and 3 others.

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  Srm University

  Engineer'S Degree