By Joseph Williams, Strategic Engagement Lead – Language Access & Inclusion
At THG Fluently, we translate close to one million words of pharmacovigilance (PV) content every month. That volume includes ICSRs, DSURs, PSURs, CIOMS forms, line listings, and aggregate reports across every major language pair.
At that scale, the risks within a PV translation operation become visible very quickly. Three issues appear consistently across CROs and pharma safety teams of different sizes, regardless of their internal setup.
If your team processes ICSRs and relies on an external language services partner, you will likely recognise at least one of these risks.
Risk 1: Terminology drift quietly corrupts your coding
Signal detection lives or dies on correct MedDRA preferred terms. When a translator reaches for a synonym, even a reasonable-sounding one, instead of the exact mapped term, that report lands in your system with an error baked in. Your coding team catches it, or worse, your regulatory submission does.
The root cause is almost always the same: translators working without compound-specific glossaries. Generalist agencies tend to operate this way. At low volumes it’s manageable. At scale, say a million words a month, even a modest error rate creates a correction burden that starts to hurt.
The fix isn’t complicated. Your translation partner should maintain a terminology database built around your compounds. Every linguist touching your reports should be trained on it. An independent review should happen before anything reaches your team.
Risk 2: Volume spikes without qualified capacity in place create real compliance exposure
Post-market signals happen. Class-label updates, regulatory queries, unexpected case surges all drive volume up fast. Your translation partner needs to absorb that increase without slipping on turnaround.
Most generalist agencies can’t do this reliably. The problem is that ICH E2A doesn’t care about your vendor’s staffing situation. Expedited reporting for serious, unexpected adverse reactions still requires submission within 15 days. The EMA and FDA don’t offer translation delays as a valid exemption.
The only way to handle this well is to build the capacity before you need it. Onboarding should include sourcing 20–30% additional linguist capacity, all trained on your terminology, sitting ready. When a spike comes, the work starts immediately. You’re not waiting for new people to get up to speed while your compliance clock runs.
Risk 3: Your SLA probably doesn’t reflect how you classify cases
A single 24-hour turnaround for every case sounds simple. It’s also a problem. Non-serious reports and critical ones are not the same thing, and treating them identically adds unnecessary risk to your most time-sensitive pipeline.
Your service agreement should map to your internal case classifications. A reasonable structure looks something like this:
- Critical cases: 2–5 hours
- Serious cases: within 12 hours
- Non-serious cases: 12–24 hours
Agree on those timelines, put them in writing, and run a proper test before you process any live cases. If your current partner offers only a flat turnaround for everything, that’s a gap in your compliance process worth addressing now.
The common thread across all three
None of these risks are inevitable. They tend to show up when PV translation is treated as a commodity service rather than a specialist discipline. The linguists working on your reports should have relevant qualifications and meaningful PV experience, ideally three or more years. Your terminology should be actively managed, not static. Your SLAs should reflect regulatory reality. And your operational capacity should be built in advance, not assembled mid-crisis.
If you’re not sure whether your current setup holds up under scrutiny, it’s worth a conversation.