Software Used in Pharmacovigilance | Yuva Infocare
Author : Anjali Singh | Published On : 02 Sep 2026
What Software Is Used in Pharmacovigilance?
Pharmacovigilance isn't a single task — it's a whole set of processes, and different types of software are used at different stages. Understanding what software is used in pharmacovigilance helps teams figure out what they actually need, instead of buying tools that don't fit their workflow.
Types of Software Used in Pharmacovigilance
1. Case Processing Software Used to capture and manage Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources.
2. Pharmacovigilance Database Software The central system that stores all adverse event data securely, with audit trails and access controls.
3. Pharmacovigilance Literature Review Software Used to scan medical literature for potential safety signals related to a company's products, and to document that review process for regulators.
4. Signal Detection Software Analyzes case data to identify unusual patterns or previously unknown risks.
5. Regulatory Reporting Tools Generates submission-ready documents in formats like E2B XML, MedWatch, and CIOMS.
6. MedDRA Coding Tools Helps classify adverse events using standardized medical terminology.
Do You Need Separate Tools or One Platform?
Some organizations use separate tools for each function, but that often creates data silos and extra manual work. A unified pharmacovigilance database that also covers literature review, coding, reporting, and signal detection tends to be more efficient and easier to keep compliant.
How ARS PV Brings These Tools Together
ARS PV is designed to cover the full range of software used in pharmacovigilance, all within a single system. It includes case processing with AI-assisted duplicate detection, an inbuilt pharmacovigilance literature review tool, MedDRA coding support, a customizable report builder, and regulatory submission tracking — all built to comply with FDA 21 CFR Part 11, ICH E2B, GAMP 5, and HIPAA standards.
