PV
The science of detecting and managing adverse drug effects after marketing.
Definition
Pharmacovigilance (PV) is the discipline of detecting, assessing, understanding, and preventing adverse drug effects after marketing. Mandatory PV obligations include FAERS reporting (US), EudraVigilance (EU), PSUR/PBRER submissions, and Risk Management Plans. Disproportionality analyses (PRR, ROR, EBGM) flag emerging signals.
See also
- FAERS — The FDA database of post-marketing adverse event and medication error reports.
- Adverse event — Any untoward medical occurrence in a patient receiving a drug, regardless of causality.