GVP Auditing Services

Pharmacovigilance Services — Building Systems That Actually Work

When PV Work Overwhelms Your Team

You know the pattern.  PV backlogs are growing faster than you can clear them. Case intake is taking 8 days when it should take 3. Signal management that exists on paper but doesn’t work in practice. Training logs that appear satisfactory but fail to accurately reflect actual competency. QPPV arrangements without functioning systems underneath.

The work matters. Patient safety depends on it. But keeping up with TGA expectations while managing operational reality feels unsustainable.

I’m the person teams call when they need to get back ahead.

I’m Carl Bufe — The AI-Native GxP Practitioner. Not a consultant who writes audit reports from the sidelines. A practising QPPV, auditor and director who steps in where pressure is highest and builds inspection-ready pharmacovigilance systems alongside your team.

I don’t disappear after finding gaps. I help you close them, document everything thoroughly, and transfer the capability so you own the system.

Why Pharmacovigilance Auditing and Implementation Matter

The Therapeutic Goods Administration (TGA) expects medicine sponsors in Australia to maintain robust pharmacovigilance systems that protect patient safety throughout a product’s lifecycle. This means:

• Timely adverse event collection, assessment, and reporting aligned with regulatory deadlines
• Traceable case management and signal detection with clear evidence trails
• Current governance documentation — SOPs, risk management plans, signal trackers, SDEAs — that work in practice, not just in theory
• Clear local accountability through properly supported QPPV or A-PVCP arrangements
• Effective quality systems with CAPA closure that actually prevent recurrence

Compliance isn’t about passing inspection. It’s about building systems that can withstand TGA scrutiny because they genuinely work to protect patients.