- ITI Corporate Member No. 00030335
- ISO 17100 Aligned
- Human-Only — No MT
- 220+ Languages
Specialist service
Pharmacovigilance Translation Services
Human-only translation of adverse event and safety documentation — no AI, no MT, no post-editing, at any stage — produced by linguists who understand MedDRA terminology and EMA Good Pharmacovigilance Practice (GVP) reporting requirements, for pharmaceutical companies, CROs and regulatory teams.
Pharmacovigilance translation carries a different kind of pressure to most regulated content: the clock. A mistranslated adverse event narrative doesn’t just introduce an error, it can delay a safety signal. We work to the reporting deadlines your PV team is already held to — 7-day expedited and 15-day non-expedited reports under EMA GVP Module VI — with human translation at every stage, because AE narratives are exactly the kind of fragmentary, high-consequence content where machine translation and post-editing introduce risk we’re not willing to pass on to you.
Document types we translate
• Adverse event (AE) narratives
• Individual Case Safety Reports (ICSRs)
• Periodic Safety Update Reports (PSURs)
• Development Safety Update Reports (DSURs)
• Risk Management Plans (RMPs)
• Safety Data Exchange Agreements (SDEAs)
• Benefit-risk assessments
• Signal detection reports
Why pharma teams and CROs choose TIL for PV translation
Subject-Matter Matching. Every PV project is assigned to a linguist with verified experience in pharmacovigilance terminology — not a generalist medical translator. Our linguists work with MedDRA terminology, signal detection principles, and the causality assessment language PV departments use daily.
Human-only, No Exceptions. No machine translation, AI, or post-editing at any stage — the same standard we apply across every service we offer. AE narratives are often fragmentary, inconsistent, or written by a non-native speaker under time pressure — rendering a coherent, accurate account from that source material is a job for a specialist, not a model.
Data Handled With Care. Pharmacovigilance documents carry patient safety data. We handle all PV content in line with GDPR, with confidentiality and restricted access built into our workflow as standard, not an add-on.
Built For The Deadline. We understand 7-day and 15-day GVP reporting windows and can discuss priority turnaround for urgent submissions.
Documented Quality. Every project includes a signed Certificate of Accuracy. If independent review is required, we provide a Certificate of Translation Quality via our Independent Translation Review service.
Languages
Our PV linguists work across Dutch, German, French, Italian, Spanish, Polish and other European languages, with English as the standard target for EMA and MHRA submissions. See our full language coverage →
Frequently Asked Questions
How fast can you turn around an urgent ICSR?
We can discuss priority turnaround against your specific GVP reporting deadline — get in touch with the document and deadline and we’ll confirm feasibility within the hour during business hours.
Do you use machine translation for pharmacovigilance content?
No. Pharmacovigilance translation at TIL is human-only, at every stage, with no exceptions — the same standard we apply across all our services. This is stated policy, not a preference we relax under time pressure.
Can you provide a certificate for our regulatory submission?
Yes — every PV translation project includes a signed Certificate of Accuracy, submission-ready for EMA and MHRA packages.
Related services
Linguistic validation & Independent Translation Review
Clinical trial translation
Life sciences translation overview
Discuss your pharmacovigilance translation project
Whether you need pharmacovigilance translation, clinical trial materials, regulatory submissions, or linguistic validation — we are happy to discuss your requirements, timelines, and language combinations.