Internal Pharmacovigilance Audits: Ensuring Regulatory Readiness

Internal pharmacovigilance audits give independent assurance that PV processes work as written and as required. A risk-based internal program catches process drift, training gaps, and vendor failures before external auditors do. Findings only help if they are evidence-based and tied to CAPA that quality will actually track to effectiveness, not close on paperwork alone.

Viltis conducts internal PV audits and co-sourced audit support for sponsors who need experienced auditors without building a full in-house PV audit bench. We scope against GVP-relevant processes, sample cases and signal files, interview process owners, and write findings that state the requirement, the evidence, and the risk. Remediation advice stays practical and fixable by the people who own the process. We also help calibrate severity so leadership can distinguish critical system breaks from local documentation noise.

Vendor audits deserve the same rigor as internal process audits, especially when case processing or literature screening is outsourced. We help define audit scopes that sample live work, not only vendor slide decks, and we push for contractual access to the evidence needed. Oversight records then show active management rather than annual certificate collection. Trending of prior findings is included so repeat issues are visible to leadership instead of resetting every cycle. Independence from day-to-day case processing is preserved in staffing.

Internal PV audit support often includes

• Risk-based annual audit planning input
• Process and system audits of ICSR workflows
• Signal, literature, and aggregate process audits
• Vendor PV audits and oversight reviews
• Finding write-ups with severity and evidence
• CAPA challenge and effectiveness check support
• Audit program reporting to PV and quality leadership

Internal audits should harden the system, not generate paper. Viltis keeps the work grounded in how cases and decisions actually move, so leadership gets a true picture of PV health. Over time, a steady internal program reduces surprise findings and makes external audits less dramatic because the organization already knows its weak spots. If your internal audit program is thin or overdue, we can run a focused cycle on the highest-risk PV processes and leave a repeatable template for the next year.