CSA Consultant, PV/Clinical/RA

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Deliver subject matter expertise in CSA / CSV across Pharmacovigilance (PV), Clinical, and Regulatory Affairs platforms.

• Assist with system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective.

• Create and evaluate validation deliverables such as Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports.

• Review and authorize lifecycle documentation (URS, specifications, test plans, test summaries) in accordance with ALCOA+ and Good Documentation Practices.

• Supervise validation readiness and ensure all prerequisites are satisfied before formal testing begins.

• Support activities related to change control, configuration management, and release processes.

• Collaborate with Quality, System Owners, and Business Process Owners to maintain ongoing compliance.

• Offer guidance on CSA-driven and risk-based validation methodologies.

• Conduct regular system compliance evaluations, validation health checks, and lifecycle assessments.

• Assist with periodic reviews, including user access evaluations, audit trail assessments, data integrity checks, and system inventory maintenance.

• Evaluate the compliance implications of deviations, incidents, CAPAs, and system issues, ensuring proper remediation and documentation.

• Review and support vendor documentation, supplier evaluations, and quality documentation from SaaS providers.

• Track regulatory inspection findings, internal audit results, and compliance trends to identify opportunities for process improvements.

• Engage in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and operational support.

⛳️ Requirements

• 5–8 years of practical experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a mix of these fields.

• Proven experience in supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a blend of these areas.

• Deep understanding of CSA principles, CSV, and SDLC processes.

• Experience in authoring and/or reviewing validation documentation.

• Familiarity with GxP regulations (e.g., FDA, EMA, ICH) and expectations regarding data integrity.

• Capability to work independently in a dynamic, matrixed environment.

• Excellent communication skills and comfort in engaging with Quality and business stakeholders.

• Preferred: Experience with enterprise platforms that support PV, Clinical, or Regulatory operations.

• Preferred: Previous role as a Validation Subject Matter Expert, CSA Lead, or Compliance Consultant.

• Preferred: Knowledge of electronic quality systems, change management tools, or application lifecycle management platforms.

🏝️ Benefits

• Opportunities for growth within a fast-paced organization that values its people.

• Competitive salary plus performance-based incentive programs.

• Company-funded Life, Short-Term, and Long-Term Disability Insurance.

• Medical, Dental, and Vision insurance options.

• Flexible Spending Account (FSA), Dependent Care Assistance Reimbursement (DCARE), and Commuter Benefits.

• Supplemental Life, Hospital, Critical Illness, and Legal Insurance.

• Health Savings Account (HSA).

• 401(k) Retirement Plan with Employer Matching benefits.

• Paid Time Off with a rollover option and designated holidays.

• Sick leave as needed.

• Tuition Reimbursement.

• Team social activities to foster a fun work environment!

• Employee recognition programs.

• Employee Referral Program.

• Paid parental leave and bereavement leave.