6598 - CSA Consultant, PV/Clinical/RA

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

We empower and support our colleagues

We commit to client success at every turn

We have the courage to do the right thing

We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.

We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Overview

We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.

Key Responsibilities

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 to ensure continued validated state and ongoing regulatory compliance.

Support periodic review activities 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 and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.

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

Required Experience & Qualifications

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

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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range$70,491—$118,062 USD

Benefits

Why Choose Verista?

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

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For more information about our company, please visit us at Verista.com