Om Bichewar Email & Phone Number

A proactive Life Science professional holds M.Pharm qualification with 14+ years of work experience & proven track record of stakeholder management, skilled in gathering business requirements, and providing Digital, Med Tech, and Therapeutic solutions as per their Business needs.  Expertise in Commercial Landscape of Life sciences in area such as, Product Launch, Market Access & Pricing, B2B Sales, Business Development, KOL Development, Medical devices consultant & Medical Science Liaison.  Profound understanding and Experience in Software Development Life Cycle (SDLC) as Senior Business Analyst and Domain Expert/ SME for Pharma and Medical Devices Clients.  Certified SAFe Agilist Professional, Experienced in Agile Methodology & work with Scrum Master for executing Scrum ceremonies such as Backlog Refinement, Sprint Planning, Stand Up, Sprint Review & Sprint Retrospective.  Delivered strategic leadership & consulting Life Sciences projects with changing priorities, ensuring focus on quality, timeliness and continuous Business Process Improvement.  Executed Interactive Data Products for Market Access & Pricing team for Pharma client using BI tools.  Executed BI Projects by Integrating with Relational Databases & other Systems such as Oracle, Redshift, Amazon S3, Apache Hive, Veeva CRM, & Dremio.  Accelerated the success of organizations by bridging the gap between Healthcare Professional & Pharmaceutical/Medical Devices Organizations.  Well versed with Regulatory Compliance such 21 CFR, (Part 11, Part 50, Part 210, and Part 211), HTA Submission, GxP (GCP, GMP, GVP, and GMLP) HIPPA/HITECH, Medical Devices Regulation (MDR), ISO 13845 and 14155 standards, EMR, HL7, ICD, Pharmacovigilance, US Healthcare (Medicare/Medicaid) and USFDA Regulatory submissions.  My domain expertise include Clinical trials, Regulatory affairs, Market Access & Pricing, Medical device consulting, & Pharma commercial Operations.