Debasis Das Email & Phone Number

Experienced PV professional. Application Developer, Database Architect, and Tech Leader in a wide variety of enterprise applications. Debasis brings over 18 years of experience architecting and implementing solutions in the life science industry. He has extensive experience with configuration design and management of safety systems and their associated business processes. His experience includes all phases of the system design life cycle with a focus on strategic planning, business process optimization, global regulatory compliance, custom system design and development, and system implementation and integration. He helps customers meet global requirements by developing and building innovative strategies in the healthcare industry. In addition to business relations, he brings technical expertise to the organization in order to meet customer needs in the most efficient manner. He has designed / re-designed and architected several pharmacovigilance tools and software packages which helped many clients in achieving their specific business needs. Along with product development, he has been an active member of the consulting teams as well. Debasis has lead business requirement RFPs, Global and Japan Database Match and Merge, User and Administrator Training for several Pharmaceuticals, Biotech, and CROs across the globe. He has extensive subject matter expertise in LSMV and ARISg Safety Suite of products. He has led several Solution assessments, RFP decisions, Business process transformations, Data clean up and performance tuning of PV-related systems.Expertise in SQL, PL/SQL, Performance Tuning, Data Migration, Workflow Design, Managing a very large-scale database for the web application. Domain expertise in Pharmacovigilance & Drug Safety, Regulatory Affairs, and Clinical Trials area. Expertise in the migration of pharma data from various safety systems like AERS, Argus Safety, SAS, Clintrace, Perceive, and ES1 into ARISg 7.x and advanced version of LSMV. Extensive exposure to customization of different versions of ARISg and LSMV for over two dozen major global pharma clients. Designed over 10000+ Distribution rules for Global Case Distribution / Submission to various Authorities and Partners in different formats like E2B R2, Standard R3, FDA R3, EMA R3, PMDA R3, MFDS R3, CIOMS, MedWatch, and eMDR using ARISg's regulatory reporting matrix and LSMV's distribution reporting framework (11.x and 2022.x).Quality exposure to ETL tools like Pentaho, ODI, and Talend Studio for data integration and migration. Hands-on experience on DrugLogic Qscan-ERM 2.5.

Listed skills include Pl/Sql, Data Migration, Oracle, Sql, and 21 others.