For all the investment large pharmaceutical companies have made in digital infrastructure, the transformation of pharmacovigilance has not been consistent. Although individual case processing was transformed by safety databases in the early 2000s, that transformation didn’t extend to the surrounding workflows. Still today, aggregate report scheduling, pharmacovigilance system master file (PSMF) management, PV agreement maintenance, term collection and affiliate oversight are managed through Excel, shared drives and email.
That this situation persists in some of the most heavily-regulated organisations in the world is unfathomable; that 40-50 per cent of expert PV time is still consumed by administrative coordination rather than scientific drug safety assessment. Quite apart from the fact that no organisation has that expert time to spare, the associated inefficiency is costing companies dearly and incurring more risk than it should. And the longer the situation is allowed to continue, the greater the burden, due to the soaring demands on PV.
The challenge is how to break out of old patterns, and make a robust case for change.
Frittered hours, frustrated scientists
The worst-affected workflows, or those guilty of tying up the bulk of scientists’ time, are those that are document-intensive, dependent on multiple contributors, running on recurring cycles and requiring a traceable record. For a sizeable organisation with a broad marketed portfolio, aggregate reporting alone can mean hundreds of Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs) and annual safety reports across the calendar year.
The PSMF, meanwhile, presents an ongoing governance challenge. It must accurately reflect the current state of a company’s PV system at all times — a requirement that, across EU and local variations, demands structured review cycles, version control and traceable sign-off. Companies relying on shared drives or email trails for this have no reliable way to confirm who made a given change or whether anyone reviewed the document before it went out. Scenarios such as a PSMF arriving at inspection with a duplicated chapter or inconsistent annex data, with no audit trail to explain either, are examples of what can happen when a document that carries regulatory weight is managed via a shared folder.
PV agreement and term collection management share the same underlying problem — that the tools in use were not built for the scale or the compliance standard now required. PV agreement volumes grow with organisational complexity, and email cannot manage that growth reliably. Meanwhile MedDRA query management and its upgrade tooling has always lagged behind what modern PV requires — and most companies are well aware of this, even if they feel held back by their adopted workarounds (which may feel too embedded to dislodge easily).
An affiliate network, never quite in view
For companies running PV through local affiliates the oversight picture is, at best, incomplete. Local affiliates manage their own ICSR processing, submissions and agreement management through tools that exist beyond the central system — and central teams are left to piece together what they can from periodic updates and email exchanges. It is rarely the full picture, and central teams rarely know quite how much they are missing.
That gap matters more than it might appear, and tends to become visible at the worst possible moment — for example at the point of inspection.
Incomplete oversight can also shape day-to-day decision-making in ways that are harder to quantify. If the data informing a central safety review is only as current as the last email update from a local affiliate, for instance, the quality of that review reflects it — yet this isn’t always apparent to those making the decisions.
The case for doing something different
The major safety database platforms do what they were built to do, and they do it well. The trouble is what to do about the surrounding workflows, especially as these continue to scale.
Replacing an embedded safety database is not something most large organisations would seriously consider, and nor should they. The disruption alone would be enough to rule out such a move — not to mention the validation effort and the risk of running a live pharmacovigilance operation through a transition of that scale.
The more pragmatic approach, for most organisations, will be to build around what they already have — adding capabilities that work alongside the existing platform rather than displace it.
Pick a problem, and fix it
For most organisations, the starting point is not identifying the problem — it’s choosing which one to tackle first. Most PV functions are not short of candidates. The question is where the time cost and compliance exposure are greatest, and whether a business case can be built around it. If a senior PV professional is spending up to half their working time coordinating aggregate reports, that cost is directly calculable — and when inspection preparation is added to the picture (the hours spent reconstructing email threads and reconciling file versions just to demonstrate compliance), the case for change tends to make itself.
Regulatory readiness should not begin when an inspection is announced. Yet, for teams whose workflows rely on shared drives and email, it typically does — because the documentation needed to demonstrate compliance has to be rebuilt from scratch each time. This just isn’t sustainable in 2026. Portfolios are larger than they were a decade ago, affiliate structures more complex and regulatory expectations higher. The expert capacity to absorb all of that has not grown to match. At some point, the maths no longer compute and change becomes non-negotiable. That time has come.
About the author
Gyöngyi Mezey is director of product management at Qinecsa Solutions, where she leads development of the company’s PV workflow automation platform, drawing on nearly two decades of hands-on pharmacovigilance experience, spanning drug safety operations, clinical coding and PV consulting at organisations including PAREXEL, Roche and IQVIA. She is based in London, UK.
