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
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