Pharmacovigilance Gap Analysis: Strengthening Your Compliance Framework

A pharmacovigilance gap analysis compares your PV system (people, processes, systems, and documentation) against applicable GVP modules, FDA expectations, partner contracts, and your own Pharmacovigilance System Master File description. Gaps found in a controlled review cost less than the same gaps found during an inspection or a critical partner audit. The useful output is not a score; it is evidence of where the system breaks under real case volume or tough questions.

Viltis runs structured PV gap assessments covering ICSR processes, aggregate reporting, signal management, literature, vendor oversight, training, and quality management. Findings come with severity, evidence, and practical remediation options sequenced by risk. We compare written procedures to sampled cases and interviews so the assessment reflects practice, not only the SOP library. Partner and vendor interfaces get explicit review because many failures live in the handoff, not inside a single company wall.

Gap analyses are most useful before major events: inspection windows, new market entry, safety database migration, or QPPV transition. We time and scope the review to those triggers so remediation dollars go to the risks that matter now. Findings are written so CAPA owners can act without reinterpreting consultant shorthand. System configuration and access control are sampled where data integrity or case visibility could hide process failure. Remediation owners and due dates are required in the final report.

Gap analysis scope commonly includes

• PSMF and procedural document review
• ICSR and expedited reporting process checks
• Signal, aggregate, and literature process review
• Vendor and partner oversight evaluation
• Training, roles, and backup coverage assessment
• System and data integrity spot checks
• Prioritized remediation roadmap with owners

A useful gap analysis leaves you with a punch list leadership can fund and quality can track. Viltis delivers that read in plain language so remediation starts before the next audit window, not after a finding letter. We can stay through remediation planning to confirm that fixes address the evidenced gap rather than creating parallel paperwork no one uses. If an inspection or partner audit is scheduled, we can focus the gap review on the processes auditors sample most and turn findings into a sequenced remediation plan.