From Report to Regulator: Why Translation is the Backbone of Pharmacovigilance

Introduction

Pharmacovigilance (PV) is one of the most vital functions within the life sciences industry. Monitoring the safety of medicines and medical devices after they reach the market; collecting, assessing, and reporting adverse events (AEs) in accordance with a dizzying array of international regulatory requirements; it’s a huge responsibility. The stakes could not be higher: a single mistranslation in an adverse event report can put months of regulatory approval timelines back, trigger time- and resource-intensive re-reviews, and most importantly of all, impact the safety of patients.

In the interconnected world of global healthcare, pharmaceutical and medical device companies’ pharmacovigilance teams have the unique challenge of handling enormous volumes of safety data, coming from dozens of countries and dozens of languages. Multinational pharmaceutical companies have no choice but to translate pharmacovigilance safety data; it is not optional, it is a regulatory and business imperative.

In this blog, we look at why translation is such a core element of pharmacovigilance, examine real-world examples of translation errors creating risk, and explore best practices for building translation workflows which provide 100% compliance, accuracy, and speed.

Why does translation matter in pharmacovigilance?

Pharmacovigilance, at its heart, is about collecting real-world data. AEs come not only from healthcare professionals but also from patients, caregivers, and even direct digital sources, such as health apps. The types of AE reports they send can take any of the following forms:

• Patient-submitted spontaneous reports in their native language
• Physician notes and handwritten records full of local abbreviations, slang, and clinical shorthand
• Call center call transcripts or emails sent to medical information units
• Reports harvested from social media or patient forums
• Articles, journal publications, or scientific literature in local language journals

For multinational pharmaceutical companies, these adverse event reports must be captured, translated, and normalized before they can be loaded into global safety databases, like Argus, ArisG, Oracle Safety, or Veeva Vault Safety. And regulators, be they the FDA, EMA, MHRA, PMDA, Health Canada, or others, expect the reports of adverse events to be consistent, accurate, and complete, and to be submitted with expedited turnaround times (often within 15 calendar days of receipt for serious, unexpected AEs).

A mistranslation or delay, therefore, is not simply a back-office problem. It can impact patient safety and regulatory compliance.

Real-world examples of risk from mistranslation

Case example: MHRA’s Oncology Report Findings (2022)

In 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a series of adverse event reports from oncology products where translations from Eastern European languages had introduced errors. In one case, the term “seizure” was mistranslated as “tremor”.

A seizure is a serious, potentially life-threatening neurological event.

A tremor, while also a serious event, does not have the same clinical urgency or regulatory severity.

This and other errors forced regulators to order re-review of dozens of case safety reports (CSRs). Pharmacovigilance resources were strained, and the incident revealed the risks of sending translations through low-cost or unqualified translators without adequate QA.

Case example: Large Pharma with Dedicated PV Teams

In response to growing regulatory and safety risks, some larger pharmaceutical companies, such as Roche, have created dedicated pharmacovigilance translation units. These teams are trained not only in linguistic and medical terminology but also in adverse event coding (e.g., MedDRA) and regulatory reporting standards. Their goal is to not simply translate, but to capture all of the information on incoming adverse event reports with clinical precision. And as global safety volumes continue to grow, driven by the proliferation of patient reporting apps, EHR systems, and digital monitoring of social media platforms, the need for such specialized PV translation teams is no longer a nice-to-have. It is business-critical.

Pharmacovigilance Translation Challenges

Broadly, the translation challenge that pharmaceutical, biopharma, and medtech companies face when addressing the safe handling of PV data can be broken into three distinct areas:

Volume

The overall amount of data. PV teams are seeing ever-increasing amounts of incoming data thanks to direct-to-patient engagement, patient reporting apps, decentralized trials, etc. A single blockbuster can receive thousands of spontaneous AE reports in any given year, from over 50 countries, in many different languages.

Languages

AE reports may come in any of the over 50 common languages, from widely-spoken languages like Spanish and Mandarin to less common ones such as Latvian, Amharic, Swahili, etc. Each language has its own set of medical idioms, abbreviations, and cultural nuances.

Timelines

IEC E2D guidelines and various national regulatory policies require serious AEs to be reported within very short deadlines, often 7 (if fatal or life-threatening) or 15 calendar days or fewer in the EU. Delays on the translation layer can impact the ability of companies to meet these deadlines, and risk regulatory noncompliance. Compounding the challenge, adverse event reports often arrive unpredictably, in sudden clusters or at unexpected times, making it difficult to anticipate workload and allocate translation resources in advance.

Linguistic Precision in Pharmacovigilance

PV is not simply a matter of “translation” in the usual sense. It is a matter of precise interpretation of medical terminology, regulatory reporting standards, and the clinical context of terms. Consider these examples:

• Stroke vs. Transient Ischemic Attack (TIA) Misunderstanding these can impact severity.
• Allergy vs. Hypersensitivity A general reaction vs. a specific immune response.
• Hospitalization vs. Observation One requires regulatory reporting; the other may not.

Translators who work in PV also need fluency in the MedDRA coding system. MedDRA is a dictionary that standardizes AE terms across all safety databases. If the source report is mistranslated, then it is possible to code it with the wrong MedDRA term, compromising the accuracy of the safety database itself.

Speed vs. Accuracy: Finding the Balance

One of the critical tensions pharmaceutical companies face is the need for both speed and accuracy. Speed, because regulators expect these reports to be turned around within days, not weeks, and real-time pharmacovigilance systems are now common. Accuracy, because the incoming AE reports must be medically precise, consistent, and devoid of any ambiguity. Striking the balance between speed and accuracy requires both the right technology and the right workflows. The key is often hybrid, not “all human” or “all machine” workflows.

Best practices for Pharmacovigilance Translation workflows

Drawing on experience from clients across pharma, biopharma, and medtech, below are some of the best practices for setting up workflows which ensure that all PV translations meet both regulatory and operational requirements.

1. Use specialized medical linguists

Generalist translators who may have translation or editing experience are not, in and of themselves, qualified to work on PV. PV translators must have:

• Medical/life sciences backgrounds
• Familiarity with MedDRA coding
• Experience with regulatory reporting standards

2. Implement MT + Human Post-Editing

Machine translation (MT), particularly from AI-optimized neural engines, can be used to accelerate TAT for large, ongoing PV AE reports. Machine translation should not be used for all-encompassing translation without human medical editing. Human medical editors should review and correct machine output to ensure accuracy.

3. Create centralized translation memories & glossaries

Terminology and glossaries are critical. Companies should build dedicated PV glossaries and translation memories that include:

• Drug medicine names and INNs (international nonproprietary names)
• Standard medical terms
• Regulatory terminology required in certain markets

4. Integrate directly into safety databases

Translation and QA workflows should be able to integrate with safety databases. (Oracle Argus, ArisG, Veeva Vault Safety, etc.) Automated connectors can send translated and post-edited AE reports directly into the safety database, without human copy-paste errors or duplication of work.

5. QA and back-translate all critical Pharmacovigilance reports

For high-severity AE reports (fatalities, serious risks, etc. ), we recommend back-translation and multiple layers of QA. Regulators should have full confidence in the quality and accuracy of these reports.

6. Train for low-resource languages

It is not unusual for companies to receive AE reports in languages for which they have not pre-vetted translators or built a glossary. To handle this situation, PV teams must train and build glossaries for even the most “low-resource” languages, ahead of time. Ad hoc translation of uncommon languages almost always results in errors and delays.

The Future of Pharmacovigilance Translation

The world of PV translation is rapidly changing, driven by the following three key trends:

1. AI-Driven Automation

Generative AI and NLP tools are being trained on large safety databases of AE reports. These tools can provide first-pass translations of adverse event narratives, identify and highlight inconsistencies, and even suggest MedDRA coding for reported AEs.

2. Real-Time Multilingual AE Reporting

As patient-facing apps and wearables gain wider adoption, real-time capture of AEs is already a reality. In the future, multilingual translation of patient-reported outcomes and safety data will need to be immediate.

3. Harmonization of Reporting Standards

Regulators have moved toward greater harmonization in terms of reporting standards. The FDA, EMA, PMDA and other regulatory bodies are all aligned around using MedDRA. However, translation standards are still highly fragmented. We expect to see industry and advocacy groups pushing for global standards on PV translations in future years.

4. Patient-Centricity and Plain Language

The trend toward patient-centricity has pushed regulators to require patient-facing documents like lay summaries of clinical trials to be written in simpler, more understandable language. This, too, is coming to pharmacovigilance. Patient-reported AEs must be translated accurately but also with a plain-language and patient-centric tone.

Conclusion

PV translation is a high-risk/high-reward endeavor. The examples of MHRA’s oncology reporting findings and dedicated PV teams at Roche give a sense of both the risks and the best practices of PV translation in the real world.

Pharmaceutical, biopharma, and medtech companies are under no illusions. Translation is no longer a back-office function. It is a core part of regulatory compliance and patient safety. Companies that invest in the right workflows, AI-optimized processes, and highly-trained medical linguists can reduce their regulatory risk and, by extension, build trust with patients and regulators.

In a globalized world of healthcare, where real-world safety data is flowing in from around the world and across language borders in real time, it is clear: accurate translation is the invisible backbone of pharmacovigilance. Without it, the whole system breaks. With it, patients everywhere can be safer, faster.

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