Principal Programming Analyst in Bombay, भारत

Principal Programmer Analyst role supporting Pharmacovigilance system implementations and Computer System Validation at a life-sciences technology company. Leads complex validation strategies, ensures regulatory compliance, and drives process improvements across clinical trial and drug safety systems.

Responsibilities

• Lead validation strategies and oversight for PV system implementations, upgrades, and complex technical enhancements
• Define requirements with stakeholders and ensure translation into testable, compliant functional specifications
• Plan, author, and execute system testing activities including SIT, UAT, and performance qualification
• Own validation deliverables including plans, specifications, test protocols, and compliance documentation
• Drive continuous improvement and standardization initiatives across PV validation processes

Requirements

• Expert-level knowledge of Computer System Validation (CSV) and GxP regulations
• Deep experience with Pharmacovigilance systems and 21 CFR Part 11 compliance
• Proven ability to lead requirements definition and risk-based validation strategies
• Strong technical acumen in system integrations, data migrations, and testing methodologies
• Experience mentoring validation professionals and cross-functional technical teams
• Knowledge of AI and automation applications in validated environments