At HAROM India, I lead the design and validation of HAROM Safety Vault, an E2B (R2/R3)-compliant SaaS safety database, translating ICH, GVP, FDA, and EMA requirements into configurable ICSR workflows, reporting logic, RBAC, and audit trails. I also lead CSV activities and established inspection-ready QMS documentation, deviation/CAPA, change control, and document-control processes.
I independently built OnePV, a multi-tenant AWS platform for signal and literature monitoring, including automated signal evaluation workflows, statistical and Bayesian disproportionality methods, FAERS/openFDA and PubMed integrations, and PDF/Excel reporting. Across Continuum India and Parexel, I managed end-to-end ICSR operations, coding, narratives, QC, regulatory timelines, training, and CAPA activities.
