Over 20 years of experience in Clinical Data Management and Pharmacovigilance.
Led a team of Managers / General manager / Vice Presidents involved in Clinical Trials, Pharmacovigilance and Data Management Services.
Expertise on Implementation of GxP Guidelines, 21 CFR Part 11 (Electronic data security), HIPAA (Protected Health Information security), Six Sigma (Operational), ISO 9001:2008 (Quality), ISO 27001, BS 7799 (Information Security), and guidelines pertaining to Clinical Trial Services (CTS) and Pharmacovigilance.
Over 24 years of leadership roles in pharmaceutical industry and academia.
Successfully built pharmaceutical manufacturing operations, technical teams, quality operations, and profitable business operations.
Supported more than 75 biopharma companies with their Investigational New drug (IND), and New Drug Application (NDA) products in United States of America.
Delivered more than 500 product development projects including development, manufacturing and supply of clinical trial materials.
Published many research articles, book chapters, over 75 scientific abstracts on drug formulations and delivery systems.