Ashwini Shetty

Pharmacovigilance Programs – PV SME & Validation Lead

• Led end-to-end Oracle Argus Safety upgrades and migration programs (v6.x to v8.4) for global pharmaceutical and biotech clients across the US, EU, and Japan.
• Served as Pharmacovigilance Subject Matter Expert (SME) for case processing, regulatory reporting, and compliance initiatives involving EMA R3, eVAERS, eMDR, and E2B R3 reporting.
• Designed and executed Computer System Validation (CSV) strategies aligned with GAMP 5 and 21 CFR Part 11 guidelines.
• Authored and reviewed validation deliverables including URS, FRS, Design Specifications, Configuration Specifications, IQ/OQ/PQ, Test Plans, RTM, and Validation Summary Reports.
• Managed large-scale System Testing, Integration Testing, Regression Testing, and User Acceptance Testing (UAT) across multi-region teams.
• Led post-production hypercare and stabilization activities to ensure business continuity and operational readiness.
• Coordinated directly with Oracle Product Engineering teams for defect triage, patch validation, and regulatory updates.
• Conducted business workshops covering discovery, requirement gathering, configuration optimization, and PV roadmap planning.
• Facilitated “day-in-the-life” workshops and business process reviews to improve operational workflows and compliance alignment.

Testing Leadership & Automation

• Managed testing governance for a major US healthcare client portfolio supporting 300+ applications across clinical research, compliance, and commercial systems.
• Established and led a Testing Center of Excellence (CoE) focused on standardization of testing frameworks, traceability, governance, and reporting.
• Directed release planning, defect management, environment coordination, and testing execution across onsite and offshore teams.
• Developed automation accelerators and Delta Feature Assessment tools for Argus upgrade programs, reducing manual assessment and testing effort.
• Leveraged AWS and Python-based utilities to streamline configuration validation, status tracking, reporting, and deployment activities.
• Improved testing efficiency through standardized processes, automation enablement, and optimized configuration management practices.

Project & Program Management

• Managed multiple cloud migration and platform modernization initiatives using AWS technologies for leading pharmaceutical clients.
• Led strategic transformation programs supporting modernization of legacy PV systems into cloud-enabled platforms.
• Conducted steering committee meetings, risk management discussions, resource planning, budgeting, forecasting, and vendor coordination activities.
• Supported project sales and proposal development activities including effort estimation, capability presentations, and solution planning.

• Executed end-to-end testing for healthcare and pharmacovigilance applications including interfaces, migrations, and portal systems.
• Performed system validation, regression testing, and User Acceptance Testing (UAT) for regulated healthcare applications.
• Authored testing and validation documentation including test cases, test plans, traceability matrices, and summary reports.
• Collaborated with onsite stakeholders for requirements analysis, issue resolution, and release coordination.