Pharmacovigilance·DG Japan

Pharmacovigilance

Post-marketing and clinical safety case management. Source: Oracle Argus Safety, integrated with WHO-DD and MedDRA 27.0. Supports E2B(R3) regulatory submissions.

Steward · Technical steward · Anatomy · systemic

Avg. quality

Assets

Total rows

6,052,905

Certified

/ 5

Source systems

Source systemsOracle Argus SafetyOracle Empirica SignalVeeva Vault RIM

Common tagssafety · 2icsr · 1e2b · 1meddra · 1coding · 1glossary · 1definition · 1sae · 1

Assets

Asset

Type · Status

Rows

Quality

Updated

Safety Cases (Argus)
Restricted
argus_safety_cases
Individual case safety reports (ICSRs) from Oracle Argus. Includes seriousness, expectedness, causality, MedDRA-coded reactions, WHO-DD coded suspect drugs. E2B(R3) compliant.
TableApproved
1.8M
96
16d ago
MedDRA Reaction Coding
Confidential
argus_meddra_coding
MedDRA 27.0 coded preferred terms (PT), high-level terms (HLT), and SOC for adverse reactions. Updated quarterly with MedDRA releases.
TableApproved
4.2M
98
17d ago
Serious Adverse Event (SAE)
Internal
term_serious_ae
Definition of SAE per ICH E2A: results in death, life-threatening, hospitalization, persistent disability, congenital anomaly, or other medically important.
Business TermApproved
—
100
1y ago
PV Signal Detection (PRR/ROR)
Confidential
argus_signal_detection
Disproportionality scores (Proportional Reporting Ratio, Reporting Odds Ratio, IC) computed quarterly for marketed products. Feeds signal management workflow.
TableUnder Review
9.4K
84
29d ago
PSUR / PBRER Summary
Restricted
rpt_psur_summary
Periodic Safety Update Report aggregated metrics by product. Output feeds Veeva Vault RIM for regulatory submission.
ReportApproved
—
95
1mo ago