Pharmacovigilance System Master File Best Practices

Why Your Pharmacovigilance System Master File Is the First Thing an Inspector Opens

People joke that PSMF also stands for "potential source of major findings," and there's a reason the joke sticks. It's usually the first document an inspector opens, and it's a direct reflection of your whole pharmacovigilance system. If it's not top notch, that's the impression the rest of the inspection starts from.

Tomislav Marković, Senior Pharmacovigilance Manager, sits down with Beáta Bačová, our Head of Project Management, to talk about what keeps a Pharmacovigilance System Master File (PSMF) inspection-ready, and what quietly lets it slip.

A Living Document, Not a Filing Cabinet Exercise

The first point is simple but easy to ignore: a PSMF isn't something you write once and file away. It needs a defined update periodicity, and quarterly has become the informal industry standard. Getting there takes more than SOPs. Tomislav points to something less obvious: a culture of ownership. The data comes from regulatory, marketing, medical, and other departments, since no PV professional can track everything happening across a company alone.

That's exactly where things go wrong. People get pulled into daily tasks, the PSMF gets deprioritized, and then an inspection announcement lands and everyone is rushing to collect contributions at once. Tomislav and Beáta frame this as a project management problem as much as a PV one, which is why iVigee runs it with a dedicated PSMF administrator rather than folding it into a project manager's other work.

Tomislav is currently managing roughly 30 PSMFs. Managing 15 PSMFs or 30 doesn't have to mean 15 or 30 times the work. With a modular, global approach, only the territory-specific pieces change.

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By Gemma Dailly

Marketing Director

Gemma Dailly is Marketing Director at iVigee and a seasoned marketing professional with extensive experience across clinical research and healthcare technology. Having held senior marketing roles at CluePoints and AARDEX Group, she specialises in building high-growth brands, developing strategic marketing programmes, and turning complex industry challenges into compelling stories that resonate with customers and stakeholders alike.

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