CSA / CSV Consultant - Pharmacovigilance, Clinical & Regulatory Affairs

Location: King of Prussia, PA / Remote

Position Overview

The organisation is seeking an experienced Computer System Assurance (CSA) / Computer System Validation (CSV) Consultant to support GxP-regulated systems across Regulatory Affairs, Pharmacovigilance (PV), and Clinical operations.

The successful candidate will have hands-on validation experience with systems used within at least one of these three areas, with experience across multiple areas considered advantageous.

Relevant platforms may include Veeva RIM, Argus, Veeva Safety, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), eTMF, and similar regulated enterprise applications.

This position requires someone who has owned or supported the validation lifecycle from start to finish, rather than only contributing to individual pieces of the process. This includes validation planning and risk assessment through test script development, test execution, traceability, issue resolution, and completion of the final Validation Summary Report.

The consultant will work closely with Quality, IT, System Owners, Business Process Owners, and other stakeholders to ensure regulated systems are implemented, maintained, and operated in accordance with applicable GxP regulations, data integrity expectations, and internal procedures.

Key Responsibilities

• Provide CSA / CSV subject matter expertise for systems supporting Regulatory Affairs, Pharmacovigilance and Clinical operations.
• Take an active, hands-on role across the full validationlifecycle, including:
  • Validation planning
  • Risk assessments
  • Requirements and specifications
  • Traceability matrices
  • Test script development
  • Test execution and evidence
  • Issue/deviation resolution
  • Validation Summary Reports
• Support system implementations, enhancements, integrations, upgrades and data migrations from a compliance and validation perspective.
• Develop, review and approve validation deliverables, including Validation Plans, Risk Assessments, Traceability Matrices and Validation Summary Reports.
• Review and approve lifecycle documentation, including URS, specifications, test plans, test scripts and test summaries, in alignment with ALCOA+ principles and Good Documentation Practices (GDP).
• Oversee validation readiness and ensure prerequisites are completed prior to formal testing.
• Support change control, configuration management and system release activities.
• Partner with Quality, System Owners and Business Process Owners to maintain ongoing compliance.
• Provide guidance on CSA-based, risk-driven validation approaches.
• Conduct periodic system compliance reviews, validation health checks and lifecycle assessments to ensure systems remain in a validated state.
• 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 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 opportunities for improvement.
• Participate in governance and compliance review forums, providing CSA guidance throughout the system lifecycle.

Required Experience & Qualifications

• 5-8 years of hands-on experience supporting GxP-regulated computer systems within life sciences.
• Hands-on validation experience within at least one of the following areas is required:
  • Regulatory Affairs
  • Pharmacovigilance / Drug Safety
  • Clinical
• Experience validating systems such as Veeva RIM, Argus, Veeva Safety, CTMS, EDC, eTMF, or comparable platforms.
• Demonstrated experience owning or supporting validation activities from planning through completion, rather than solely reviewing documents or contributing to individual phases.
• Practical experience with validation planning, risk assessments, requirements, traceability, test scripts, test execution and Validation Summary Reports.
• Strong understanding of Computer System Assurance (CSA), Computer System Validation (CSV), and Software Development Life Cycle (SDLC) processes.
• Experience authoring and reviewing validation documentation.
• Working knowledge of applicable FDA, EMA and ICH regulations and guidance, along with GxP data integrity expectations.
• Strong understanding of ALCOA+ principles and Good Documentation Practices.
• Ability to work independently within a fast-paced, matrixed environment.
• Strong communication skills and the ability to work effectively with Quality, IT and business stakeholders.

Preferred Experience

• Experience across more than one of Regulatory Affairs, Pharmacovigilance and Clinical.
• Experience with enterprise platforms such as Veeva RIM, Veeva Safety, Argus, CTMS, EDC or eTMF.
• Previous experience as a Validation SME, CSA Lead, CSV/CSA Engineer or Compliance Consultant.
• Familiarity with electronic quality management systems, change management tools or application lifecycle management platforms.
• Previous experience within pharmaceutical, biotechnology or broader life sciences environments.