6598 - CSA Consultant, PV/Clinical/RA

Verista, Inc.•King of Prussia, PA

7d•$70,491 - $118,062

About The Position

Verista is seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. The consultant will work with Quality, IT, and business stakeholders to help ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures. The role provides CSA and CSV expertise throughout system lifecycles, including implementations, enhancements, integrations, upgrades, data migrations, periodic compliance reviews, and operational support. The consultant develops and reviews validation documentation, advises on risk-driven validation, supports change and release activities, and helps maintain systems in a continued validated state. The role also supports audit and inspection readiness, supplier and SaaS assessments, and continuous compliance improvement. Verista describes itself as a people-focused organization serving the life sciences industry, with a culture emphasizing colleague support, client success, doing the right thing, inclusion, and continuous learning.

Requirements

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, such as FDA, EMA, and 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 Haves

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

Responsibilities

Provide CSA / CSV subject matter expertise across Pharmacovigilance, 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, including URS, specifications, test plans, and test summaries, in alignment with ALCOA+ and Good Documentation Practices.
Oversee validation readiness and ensure prerequisites are met before 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 to support the continued validated state and ongoing regulatory compliance.
Support periodic reviews, including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation.
Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.
Monitor regulatory inspection observations, internal audit findings, and compliance trends to identify process improvement opportunities.
Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.