6598 - CSA Consultant, PV/Clinical/RA

The role

This person will provide CSA and CSV subject matter expertise to support GxP compliance activities. They will work across Pharmacovigilance, Clinical, and Regulatory Affairs systems to ensure compliance with regulations and internal procedures.

What you will do

• Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation in alignment with ALCOA+ and Good Documentation Practices
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches
• Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments
• Support periodic review activities including user access reviews, audit trail assessments, and data integrity evaluations

Required qualifications

• 5–8 years of 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 integrity expectations
• Ability to work independently in a fast-paced, matrixed environment
• Strong communication skills and comfort interacting with Quality and business stakeholders

Nice to have

• Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
• Prior role as a Validation SME, CSA Lead, or Compliance Consultant
• Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

Benefits

• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities
• Employee Recognition

About the company

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The company provides innovative solutions and services that empower informed decision-making.