Pharmacovigilance
The science and practice of monitoring and reporting drug safety after approval.
What it means
Pharmacovigilance is the discipline of detecting, assessing, understanding, and preventing adverse effects and other drug-related problems. It includes the collection and reporting of SAEs, SUSARs, periodic safety update reports, and risk management plans. In Latin America, pharmacovigilance documents must be translated into local languages and submitted to local regulators.
Why it matters for LATAM submissions
Pharmacovigilance translations are subject to strict timelines and audit. Inaccurate translations can affect safety signal detection and create regulatory compliance risk.
Relevant regulators
Related terms
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