Principal Programming Analyst
Core
Senior technical and Computer System Validation (CSV) subject matter expert leading validation activities for complex Pharmacovigilance (PV) systems and initiatives.
Role type
Principal Programming Analyst (CSV SME)
Builds
Validated GxP systems, PV system implementations, upgrades, integrations, and data migrations
Domain
Life Sciences / Pharmacovigilance / Computer System Validation
Required skills
Computer System Validation (CSV), Pharmacovigilance (PV) systems, GxP compliance, 21 CFR Part 11, risk-based validation, System Integration Testing (SIT), User Acceptance Testing (UAT), data integrity, electronic records/signatures, regulatory inspections, cross-functional stakeholder management, process automation, AI adoption in GxP environments
Preferred skills
AI and automation capabilities for validation, emerging technologies in GxP, modern validation methodologies
Technologies
GxP systems, PV systems, validation tools, automation frameworks
Responsibilities
Lead requirements definition and solution assessment for PV systems; Define and oversee risk-based validation and testing strategies; Serve as senior SME for CSV and regulatory compliance; Own validation deliverables throughout the system lifecycle; Champion AI-enabled innovation in validation processes; Lead resolution of complex cross-functional system issues; Act as strategic liaison among stakeholders; Provide validation leadership within project governance; Review and recommend improvements to validation procedures and standards; Lead regulatory inspections and audits; Maintain expertise in evolving regulatory expectations
Seniority
Principal, strategic oversight & mentorship