Pharmacovigilance Business Analyst (BA) / CSV Specialist

Job Summary

We are seeking an experiencedPharmacovigilance Business Analyst (BA) / CSV Specialist to support and enhance pharmacovigilance (PV) systems, ensuring compliance with regulatory requirements and industry standards. The ideal candidate will bridge business and technical teams, gather requirements, support system implementations, and perform validation activities in accordance with GxP, FDA, EMA, and other applicable regulations.

Key Responsibilities

Business Analysis (BA)

• Gather, analyze, and document business requirements for Pharmacovigilance systems and processes.
• Collaborate with Safety Operations, Clinical, Regulatory Affairs, QA, and IT stakeholders.
• Prepare Business Requirement Documents (BRD), Functional Requirement Specifications (FRS), User Stories, and process flows.
• Participate in system implementation, enhancement, migration, and integration projects.
• Conduct gap analysis and recommend process improvements.
• Facilitate workshops, stakeholder meetings, and UAT activities.
• Support configuration and change management activities.

Computer System Validation (CSV)

• Execute CSV activities for GxP-regulated Pharmacovigilance applications.
• Prepare and review validation deliverables including:
  • Validation Plan (VP)
  • Risk Assessment (RA)
  • Functional Specifications (FS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Traceability Matrix (TM)
  • Validation Summary Report (VSR)
• Ensure compliance with FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and company SOPs.
• Coordinate validation testing, defect management, and documentation review.
• Support audit and inspection readiness activities.
• Review change controls and assess validation impacts.

Required Skills

• Strong understanding of Pharmacovigilance processes including:
  • Case Processing
  • Adverse Event Reporting
  • Signal Detection
  • Aggregate Reporting
  • Risk Management
• Experience with PV systems such as:
  • Oracle Argus Safety
  • ArisG
  • Veeva Vault Safety
  • SafetyEasyPV
• Hands-on experience in CSV and GxP validation.
• Knowledge of FDA 21 CFR Part 11, GAMP 5, ICH Guidelines, and EU Annex 11.
• Experience with SDLC, Agile, and Waterfall methodologies.
• Strong documentation and stakeholder management skills.

Preferred Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or related field.
• Relevant certifications in CSV, GAMP, Agile, or Business Analysis.
• Experience in pharmaceutical, biotechnology, or life sciences organizations.

Nice to Have

• Experience with Data Migration and System Integration projects.
• Knowledge of Jira, Azure DevOps, HP ALM, or Quality Center.
• Exposure to cloud-based validated systems.

Key Competencies

• Requirement Gathering & Analysis
• Pharmacovigilance Domain Expertise
• CSV & Compliance
• Stakeholder Management
• Risk Assessment
• UAT Coordination
• Documentation Excellence
• Problem Solving & Analytical Thinking