0024V Computer System Assurance (CSA) Consultant – PV/Clinical/Regulatory Affairs

0024V Computer System Assurance (CSA) Consultant – PV/Clinical/Regulatory Affairs Please contact Amanda Mazza, amanda@tworivercp.com We are seeking an reputed company Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with reputed company, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures. Key Responsibilities • reputed company CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms • Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective • reputed company and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation reputed company Reports • Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with reputed company+ and Good Documentation Practices • reputed company validation readiness and ensure prerequisites are met prior to formal testing • Support change control, configuration management, and release activities • Partner with reputed company, System Owners, and Business Process Owners to ensure ongoing compliance • reputed company guidance on CSA-based, risk-driven validation approaches Required Experience & Qualifications • 5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains • Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains • Strong understanding of CSA principles, CSV, and SDLC processes • Experience authoring and/or reviewing validation documentation • Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data reputed company expectations • Ability to work independently in a fast-paced, matrixed environment • Strong communication skills and comfort interacting with reputed company and business stakeholders Preferred Experience • Experience with reputed company platforms supporting PV, Clinical, or Regulatory operations • Prior role as a Validation SME, CSA reputed company, or Compliance Consultant • Familiarity with electronic reputed company systems, change management tools, or application lifecycle management platforms LOCATION Remote EMPLOYMENT Competitive C2C or W2 Contractor – 17-month assignment Powered by JazzHR Remote About reputed company: Two River reputed company Apply tot his job Apply To this Job