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Deploys and manages IBM Guardium solutions for enterprise data security and compliance, covering data protection, auditing, vulnerability assessment, sensitive-data discovery, encryption key management, and security integrations.
6598 - CSA Consultant, PV/Clinical/RA
🕒 13 days ago
Computer System Assurance (csa)Computer System Validation (csv)Gxp CompliancePharmacovigilance
📜 Description
- Provide CSA/CSV expertise across Pharmacovigilance, Clinical, and Regulatory Affairs platforms.
- Support compliant system implementations, enhancements, integrations, upgrades, and data migrations.
- Develop and review validation plans, risk assessments, traceability matrices, and validation summary reports.
- Review lifecycle documentation and oversee readiness for formal testing.
- Support change control, configuration management, releases, and ongoing compliance with Quality and business stakeholders.
- Conduct compliance reviews, health checks, periodic assessments, and data integrity reviews; assess deviations and support remediation.
🛠️ Requirements
- 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
- 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
✨ Benefits
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life
- 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
Full job description
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
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