Atul Takiar

WORK HISTORY

SKILLS

ABOUT ATUL TAKIAR

With over 22 years of industry experience, I am a seasoned Pharmacovigilance and Regulatory Affairs consultant specializing in digital transformation and operational excellence. I have successfully led and executed complex projects across various pharmaceutical organizations.My Professional experience includes Program Management, Safety Business consulting, Argus Suite products, PVAI product implementations, Safety implementations Migrations, Integration\'s, Safety processes Designing, Development, Management and Administration, User and Administrator Training and Third Level Support for across US, Europe and Asia. I have extensive experience in the entire Argus Safety Product Suite which includes different versions of Argus Safety, Argus Insight, Argus Perceptive, Reconciliation, Data Lock Point (DLP), Argus EoSU, Argus Affiliate(LAM), DS NAV, Copy Config Utility, Technology Consulting, Client Management, E2B transmission of ICSRs to Regulatory Authorities, Signal Detection and Risk Management Systems and Pharmacovigilance Database Systems, IT/IM Validation & Compliance & Writing Software SpecificationsExtensive Expertise in Pharmaceutical Safety Systems which includes E2B Regulations (EMEA/FDA/MHLW etc.), ICSR’s, Safety Applications.Expertise In Safety Systems Implementation Safety Systems Upgrade Migration of Drug Safety Systems Integration of Drug Safety Systems Defining Business Requirements Planning and Executing IQ/OQ/PQ Preparing Risk Mitigation Plan Traceability Matrix Summary Reports Support and Maintenance of Drug Safety Systems Business Workflow Design and Configurations End User and Administration Product Training Sales Business Development Product Demo Atul has been associated with a couple of reputed software organization in his career span including Oracle HSGBU (Relsys International Inc.), Pfizer and HCL Group, IBM, Techmahindra etc.