Principal Programming Analyst
MumbaiFull-time8–14 yrsPosted over a month ago
Leadership software engineering role at Thermo Fisher Scientific in Mumbai. Needs 8+ years and a degree.
About the role
The Principal Programmer Analyst serves as a senior technical and Computer System Validation (CSV) subject matter expert supporting complex and business-critical Pharmacovigilance (PV) systems and initiatives.
What you'll do
- Provide technical and validation leadership for complex, high-impact PV system implementations, upgrades, hot fixes, integrations, gateway configurations
- Establish appropriate validation strategies based on system complexity, intended use, regulatory impact, and risk
- Lead requirements definition and solution assessment with business stakeholders
- Provide expert review and challenge to ensure requirements are complete, testable, traceable, and appropriately translated into system design and validated solutions
- Define and oversee risk-based validation and testing strategies for validated GxP systems
What you need
- Pharmacovigilance
- System design
- SOP writing
- Root cause analysis