In large pharma, a staggering 40 to 50 percent of expert pharmacovigilance time is still consumed by tasks far removed from active, scientific PV - such as the mechanics of scheduling reports, tracking down contributors, and managing documents. Despite the enormous and growing pressure on Safety functions, and the technological advances the life sciences industry has embraced elsewhere, the methods used to manage core PV workflows remain much as they were twenty years ago.
Although case processing was largely solved by safety databases back then, those platforms were designed for case management rather than for the wider ecosystem of activity surrounding it (e.g., aggregate report scheduling, pharmacovigilance system master file management, PV agreement maintenance, term collection, and affiliate oversight). In the absence of a better solution, companies largely filled those gaps using Excel workbooks, shared drives, and email inboxes.
Up to now, budget pressures and competing priorities have kept these rudimentary workflows in place. An assumption that fixing them would mean disturbing the core safety database (which few companies would sanction) has made PV workflow transformation all too easy to deprioritize.
Where Expert Time Actually Goes
The workflows carrying the heaviest inefficiency load share a common set of characteristics. They tend to be document-intensive, depend on inputs from multiple contributors, run on recurring cycles, and require a documentation trail that improvised systems can’t readily produce.
For a substantial pharma organization with a broad marketed portfolio, aggregate reporting alone can represent hundreds of Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), and annual safety report deadlines across the calendar year. The coordination overhead - managing schedules, assigning responsibilities, tracking versions, and monitoring submissions - is substantial in its own right, and it compounds as the portfolio grows in ways that can’t simply be resolved by adding more people.
The PSMF generates its own problems, existing both as a regulatory requirement and a living document that must consistently reflect the current operating state of a company’s PV system. Where multiple PSMFs exist - e.g., covering EU requirements and local market variations — that demands structured review cycles, version control, and traceable sign-off. Companies managing this through shared drives and email typically have no audit-proof review process in place; there is no reliable way to confirm who made a given change, or whether the document was reviewed before it left the organization. This could mean a PSMF arriving at inspection with a duplicated chapter or inconsistent annex data, with no audit trail to determine how. Heightened regulatory expectations in the US and Europe around inspection readiness and documentation traceability make this an increasingly exposed position.
PV agreement management presents an equivalent challenge that scales with organizational complexity. As affiliate and vendor structures expand - through licensing arrangements, co-promotion agreements and growing partner networks - the volume of agreements requiring authoring, review, approval, and exchange increases accordingly. Email and shared drive management of this process produces untracked document versions, fragmented oversight of agreement status, and compliance exposure that might not surface until an inspection.
Term collection adds further pressure. Available tooling in this space has never kept pace with what modern PV requires, and homegrown workarounds rarely solve the underlying problem. Keeping pace with bi-annual MedDRA updates is often a stretch, and the data integrity that signal detection requires is rarely there.
Local Operations, Central Risk
For large pharma companies running PV operations through local affiliates, there is a further layer of coordination risk that resides largely outside the central system. Local affiliates typically handle their own ICSR processing, submissions, reconciliation, and agreement management through locally maintained tools. Central PV functions then have to piece together their oversight picture from periodic reports, email exchanges, and whatever structural arrangements have developed over time - which means central teams are generally working from reconstructed visibility rather than real-time knowledge. Where this set-up can hold together under stable operating conditions, it can come unstuck during an inspection (e.g., requiring a complete and accurate account of both central and local activity at once), or if a serious adverse event demands rapid cross-territory escalation.
Individually, each of these gaps is manageable. Collectively, they represent a significant and ongoing diversion of the organization’s most expensive resource - the scientific expertise that exists specifically to protect patients. The volume of skilled hours diverted from actual safety work is significant, and the compounding compliance risk of untraceable documentation is stark.
Making the Case for Change
The barrier to progress is rarely lacking awareness of the problem (PV operations leads generally know with some precision how much professional time is being absorbed by coordination work), but rather uncertainty about the realistic options. The question is how to move forward without disturbing major legacy investments, and how to justify that investment against other competing priorities.
No one disputes that safety databases handle case management effectively - the major platforms have been refined over decades to do exactly that. Replacing an embedded safety database is not something most large organizations would seriously entertain, though. So how then can companies extend automation support beyond case management?
The practical path for most organizations will be to address the surrounding workflows as a separate problem - building capabilities that integrate with the existing safety database rather than competing with it.
The most tractable approach is to start narrow: identify the single process carrying the greatest combination of time cost and compliance exposure, address it, validate it, and demonstrate the return before expanding scope. If an experienced PV professional is spending up to half of their working time managing aggregate report coordination, that cost is directly quantifiable. Add the harder-to-measure cost of reconstruction work before inspections and the risk carried by a PSMF that can’t be traced through its approval history, and the case for action becomes self-evident.
One way to gauge the adequacy of current systems is to consider what inspection preparation actually involves. In organizations running PV workflows manually, it typically means days or weeks of reconstruction work - pulling together email threads, reconciling file versions, establishing who approved what and when. A system that requires that level of effort before it can demonstrate compliance is not, by any reasonable standard, a compliant system.
Without a more systematic approach, companies’ exposure will continue to grow. Drug portfolios are larger and more complex than they were ten years ago, affiliate structures have expanded, and the regulatory bar for documentation and traceability is considerably higher than it was when the current manual workflows entered practice. These converging pressures cement the case for a more intelligent approach to PV workflow management that retains a company’s established safety database at its core.
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 organizations including PAREXEL, Roche, and IQVIA. She is based in London, UK.