Pharmacovigilance covers work to detect, evaluate, understand and prevent harm or other problems linked to medicines. Safety monitoring is relevant during development as well as after a medicine becomes available. For translation, identify the particular safety documents, their purpose and the terminology applicable to the project rather than assuming every file has the same reporting context.
Updated
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.
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.
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.
From reading to a project
Review status: questions to confirm
Preserve the source distinction between adverse event and adverse reaction; do not add causality when the source does not state it.
Carry the exact source term, qualification and reference. Do not soften, strengthen or assign a seriousness category yourself.
Identify the actual files, period, source revision and intended readers. Do not infer a jurisdiction, reporting timeline or submission requirement from the term alone.
Identify actual safety files, IDs, versions and periods, approved terminology, source-question owner, Chinese reviewer and return format.
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.
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 a Chinese safety-file inquiry →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.