Pharmacovigilance is the science of monitoring the safety of medicines after they reach the market: collecting, assessing and reporting adverse effects. The documents this process produces are submitted to authorities at regular intervals; most are multilingual, time-bound and regulated. Pharmacovigilance translation comes into play at exactly this point.
Frequently translated documents include individual case safety reports (ICSRs) and adverse event reports, periodic safety update reports (PSURs/PBRERs), risk management plans (RMPs), signal assessment documents, literature searches, correspondence with authorities, and safety communications for patients and healthcare professionals.
Pharmacovigilance is governed in Europe by the EMA’s Good Pharmacovigilance Practices (GVP) guidelines and in Türkiye by the rules of the Turkish Pharmacovigilance Centre (TÜFAM) within Titck. Serious adverse events must be reported within defined deadlines, which is why translation has to be both accurate and fast.
Adverse effect terms are usually coded according to standard dictionaries such as MedDRA, and the translation must stay consistent with that coding. A single mistranslated term can cause a signal to be missed or misclassified. Pharmacovigilance translation therefore rests on a subject-matter expert translator, approved terminology and editing by an independent editor.
Specialising in medical translation for over thirty years, Mirora — ISO 9001 certified, with an ISO 17100-aligned workflow — supports the pharmacovigilance processes of pharmaceutical companies.
Adverse effect terminology (MedDRA), strict reporting deadlines and regulatory formats call for both medical knowledge and command of the regulatory framework.
ICSRs and adverse event reports, PSURs/PBRERs, risk management plans, signal assessments, literature searches and safety communications.
Serious adverse events must be reported within defined deadlines; a delayed translation puts the reporting obligation at risk.
Coding adverse effect terms according to a standard dictionary; keeping the translation consistent with that coding ensures the data is classified correctly.
The EMA’s GVP guidelines in Europe and the Titck/TÜFAM rules in Türkiye are the main ones.
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