The Role of the QPPV in Ensuring Global Pharmacovigilance Compliance

The Qualified Person for Pharmacovigilance (QPPV) is the named individual with oversight responsibility for the EU pharmacovigilance system, including the Pharmacovigilance System Master File, and for ensuring the company meets its PV obligations. The role is not ceremonial: QPPVs need access to safety data, authority to escalate, and a system that actually functions under their oversight. Viltis does not issue QPPV qualifications or licenses; we help organizations structure the role and the system around it.

Viltis supports sponsors establishing or strengthening QPPV oversight models: role descriptions, deputy arrangements, information flows from case processing and signal teams, and PSMF accuracy. We help clarify what the QPPV must see, how quickly, and how decisions are recorded. For companies using contracted QPPV arrangements, we focus on oversight evidence so responsibility is not outsourced into a vacuum. Local safety officers and affiliate contacts are brought into the model so EU obligations do not depend on a single unreachable person.

Backup coverage is a frequent weak point. Holidays, illness, and turnover should not leave the EU system without a reachable deputy who has current access and authority. We help define deputy readiness, access rights, and briefing expectations so QPPV continuity is real. That continuity is part of what inspectors probe when they test system resilience. We also review how safety signals and aggregate report conclusions reach the QPPV in time for meaningful oversight.

QPPV-related support commonly includes

• QPPV and deputy role definition
• PSMF alignment to actual PV practice
• Information flow and escalation design
• Oversight metrics and review cadences
• Contracted QPPV oversight frameworks
• Training for local PV contacts and partners
• Inspection prep for QPPV interview topics

A working QPPV model shows clear authority, current system knowledge, and a PSMF that matches reality. We help companies get there with structure and evidence, without confusing consulting support with regulatory qualification of the person. When organizational change moves PV work between vendors or affiliates, we help re-anchor QPPV oversight so the named role stays connected to live operations. If QPPV oversight feels nominal today, we help restore real information flow, deputy coverage, and PSMF accuracy so the named role can function as intended.