Pharmacovigilance药物警戒
Pharmacovigilance is the systematic monitoring, collection, and assessment of adverse events and other safety data for medicines, vaccines, and biologics after they reach the market. In life science translation, the term appears in safety reports, risk management plans, periodic benefit-risk evaluations, aggregate reports, and local regulatory submissions that must be aligned with national reporting requirements, timelines, and local language conventions.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
This term appears in pharmacovigilance agreements, periodic safety update reports, individual case safety reports, risk management plans, and local health authority portals that translation teams localize for different markets. Translators must keep event descriptions, causality terms, seriousness criteria, and medical narratives consistent, because regulators compare source and translated safety data during inspections, labeling updates, and submissions.
Translation checks
A common error is translating 'adverse event' and 'adverse reaction' interchangeably because they are near-synonyms in everyday language, but in pharmacovigilance they have distinct causality implications and regulatory definitions. Another error is normalizing or softening seriousness terms such as 'life-threatening' or 'medically significant,' which can change expedited reporting obligations, understate risk, and delay safety signals.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.