CSA Consultant, PV/Clinical/RA

Verista, Inc.

. Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms .

Posted 10/27/2026full-timeRemote • Pennsylvania • United StatesMid-LevelSenior💰 $70,491 - $118,062 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CSA and CSV principles, with a strong focus on validation documentation and compliance within GxP systems across Pharmacovigilance, Clinical, and Regulatory Affairs. Capable of conducting compliance reviews and providing guidance on risk-driven validation approaches.

Highest-signal resume keywords

GxP Systems SupportCSA PrinciplesValidation Documentation AuthoringRegulatory Compliance KnowledgeChange Management Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlansRisk AssessmentsTraceability MatricesValidation Summary ReportsALCOA+ ComplianceGood Documentation PracticesSystem Compliance ReviewsData Integrity EvaluationsLifecycle Documentation ReviewValidation Health Checks

Soft Skills

Strong Communication SkillsIndependent Work AbilityStakeholder Interaction

Tools & Technologies

Electronic Quality SystemsChange Management ToolsApplication Lifecycle Management Platforms

Industry Keywords

PharmacovigilanceClinical AffairsRegulatory AffairsGxP RegulationsFDA ComplianceEMA ComplianceICH Guidelines

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Provide 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
Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) 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 reviews including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance
Assess compliance impact of deviations, incidents, CAPAs, and system issues, ensuring remediation and documentation
Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation
Monitor regulatory inspection observations, internal audit findings, and compliance trends for process improvement opportunities
Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and operational support

Requirements

What you’ll need

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 integrity expectations
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality and business stakeholders
Preferred: Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Preferred: Prior role as a Validation SME, CSA Lead, or Compliance Consultant
Preferred: Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

Benefits

Comp & perks

High growth potential and fast-paced organization with a people-focused culture
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 (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement