Sunday, July 5, 2026

Drug Safety & Surveillance

Pharmacovigilance Tools

Signal detection, safety reporting, and drug surveillance for PV professionals.

Quick Answer

NovaPharmaNews pharmacovigilance tools support signal detection (PRR, ROR), ADR causality assessment, ICH E2A seriousness checks, SUSAR decisions, MedDRA hierarchy reference, and PSUR/PBRER planning — free for PV analysts and drug safety teams.

Pharmacovigilance professionals require structured tools for signal detection, adverse event assessment, and aggregate reporting. These free pharmaceutical tools support PV analysts, drug safety officers, and regulatory affairs teams with calculators and reference aids aligned to ICH E2A, E2B(R3), WHO-UMC, and EMA GVP module requirements.

Available Pharmacovigilance Tools

Frequently Asked Questions

Live tools include Signal Detection Metrics (PRR, ROR, chi-square), WHO-UMC Causality Assessment, Seriousness Checker (ICH E2A), SUSAR Assessment, MedDRA Lookup Guide, Aggregate Report Calendar, and Case Processing workflow reference.
Enter contingency table counts for a drug-event pair. The tool computes Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and chi-square statistics used in disproportionality analysis. Interpret alongside clinical review and validated signal detection systems.
The WHO-UMC system categorizes adverse drug reaction causality as certain, probable, possible, unlikely, conditional/unclassified, or unassessable. The causality tool walks through criteria to suggest a category for case documentation.
The Seriousness Checker evaluates death, life-threatening, hospitalization, disability, congenital anomaly, and other medically important criteria per ICH E2A. Results support ICSR and expedited reporting workflows.
A SUSAR is a Suspected Unexpected Serious Adverse Reaction in a clinical trial. The assessment tool applies a decision tree for suspected, unexpected, and serious criteria to support investigator and sponsor reporting timelines.
No. The MedDRA Lookup Guide explains SOC, HLGT, HLT, PT, and LLT hierarchy and coding workflow. Official MedDRA subscription and MSSO tools remain authoritative for regulatory coding.
Tools are educational and planning aids aligned to ICH and EMA GVP concepts. Validated safety databases and qualified PV personnel must govern actual ICSR, PSUR, and signal submission decisions.
No. All pharmacovigilance tools on this hub are free with no login required.