Pharmacovigilance resources & guides
Practical, in-depth guides on drug safety operations — plus buyer answers on deployment, compliance, and AI-assisted ICSR processing. Written for PV teams, CROs, and small-to-mid pharma.
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Latest guides
Cornerstone articles for PV teams and software buyers.
Aggregate Reporting End to End: How Periodic Safety Reports Are Built
Individual cases are firefighting. Aggregate reports are the disciplined, regulator-ready story of a product's evolving benefit–risk. This guide covers which report is needed when, how line listings and tabulations are built, and how to build the software that generates them.
Signal Detection: From First Principles to a Validated Signal
One course, three depths. Climb from first principles to disproportionality statistics and Bayesian methods, learn exactly how to build and optimise the detection pipeline, and get the cross-testing angles that prove every number is correct — with a live calculator and an animated end-to-end flow.
How Much Does Pharmacovigilance Software Cost in 2026?
Pharmacovigilance software pricing is famously opaque. This buyer's guide breaks down the real cost drivers in 2026 — licensing, hosting, validation, dictionaries, and gateways — and explains why modern platforms can deliver the same core capability for far less.
Affordable Pharmacovigilance Software for CROs and Small Pharma in India
Enterprise safety suites were built for large pharma with big IT teams. This guide explains how CROs and small-to-mid pharma — especially in India — can run a complete, compliant PV operation on a modern, affordable, cloud platform.
Oracle Argus Alternatives: Affordable PV Software Compared (2026)
Oracle Argus Safety dominates the pharmacovigilance market, but it is not the right fit for every team. This guide explains when to consider an alternative and what a modern, affordable replacement should offer.
What Is ICSR Case Processing? The Full Workflow Explained
An Individual Case Safety Report (ICSR) is the core unit of pharmacovigilance. This guide walks through the complete case-processing workflow — from multi-channel intake to regulatory submission — and shows where automation helps and where qualified people stay in control.
E2B(R2) vs E2B(R3): A Practical Guide for PV Teams
E2B is the ICH standard for exchanging Individual Case Safety Reports electronically. This guide explains the practical differences between the older E2B(R2) and the current E2B(R3), and what they mean for your submissions.
Signal Detection Methods Compared: PRR, ROR, BCPNN, and EBGM
Disproportionality analysis is the backbone of statistical signal detection. This guide compares the four methods you will meet most often — PRR, ROR, BCPNN/IC, and EBGM — in plain language, with their strengths and limitations.
Aggregate Reporting Explained: DSUR, PBRER/PSUR, and PADER
Beyond individual cases, pharmacovigilance requires periodic aggregate reports that summarise a product's safety over time. This guide explains the main report types — DSUR, PBRER/PSUR, and PADER — and what they involve.
Literature Monitoring in Pharmacovigilance: A Practical Guide
Regulators expect marketing authorisation holders to monitor the scientific literature for adverse events. This guide explains the literature monitoring workflow, the obligations behind it, and how AI-assisted screening helps.
21 CFR Part 11 Compliance in Pharmacovigilance Explained
21 CFR Part 11 is the FDA rule governing electronic records and electronic signatures. This guide explains what it means for a pharmacovigilance system, the controls it requires, and how it connects to validation and GAMP 5.
Common questions
Quick answers on the platform, AI control, deployment, and compliance scoping.
PVgenix is a modern, GxP-aligned, AI-assisted pharmacovigilance platform for end-to-end ICSR processing, powered by Bright Infonet. It covers the full safety lifecycle — from multi-channel intake to regulatory submission, signal detection, aggregate reporting, and quality management.
Cases flow from intake through triage, data entry, quality review, medical review, and submission, with duplicate detection, follow-up tracking, and versioning. The platform also includes coding and terminology management, regulatory submission and exchange, literature monitoring, signal detection, aggregate reporting, risk management, reconciliation, and an integrated quality management system.
This describes the platform's overall capability set, not a fixed shipped feature list; scope is defined per client agreement.
AI accelerates intake and data entry — automated extraction from unstructured sources, domain-segmented extraction, AI-assisted narrative generation, and confidence scoring that routes low-confidence items for human review.
AI assists intake and data entry. Qualified personnel review, edit, and approve AI-generated content before a case proceeds; regulated judgments remain with the client's PV personnel.