Pharmacovigilance Safety Database – Overview

Pharmacovigilance safety database systems are crucial in today’s life sciences world. The PV safety database acts as a repository for all the Individual Case Study Reports (ICSRs) collected for every sponsor’s medicinal product. The safety databases used in Pharmacovigilance should comply with the latest Regulatory requirements and be validated to meet various standards.

The pharmacovigilance safety database is the heart of PV activities, such as individual and aggregate safety reporting obligations of the sponsor. The key elements of aggregate reports, signal detection, and risk mitigation activities are derived from the pharmacovigilance safety database.

Freyr provides a fully managed and well-maintained pharmacovigilance safety database solution with Clinevo Safety Pharmacovigilance Database Software. Clinevo is a cloud-based, user-friendly, easy-to-use, Regulatory-compliant, and end-to-end pharmacovigilance/drug safety database software. The all-in-one system provides PV intake, case processing, Regulatory submissions/AS2 gateway, analytics, and safety signal capabilities under one platform.

The Clinevo allows Freyr to set up and maintain cost-effective and validated safety databases used in pharmacovigilance. The pharmacovigilance safety database is upgraded frequently per the internal guidelines without much downtime. It also saves considerable costs in implementation, maintenance, and upgradation. Freyr provides separate PV safety database instances to ensure the confidentiality of data.

Freyr’s Pharmacovigilance Safety Database - Salient Features

  • Transparent, optimized pricing with no compromise in functionality.
  • Complies with all current and emerging regulations, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
  • One solution to handle PV intake, case processing, submissions, AI & analytics, and safety signals.
  • Easily configurable dynamic workflows for expedited case processing.
  • Provides powerful and actionable insights.
  • Advanced automation and AI features.

Our Approach

  • End-to-end ICSR case-processing activities bundled with the PV safety database.
  • PV safety database services (hosting, servers, implementation, upgradation, maintenance, and support).

Pharmacovigilance Safety Database - Freyr Expertise

  • MedDRA & WHO DD License, Upgradation, and Maintenance.
  • Legacy PV Safety Database Migration.
  • Electronic Gateway Profile Creation Services.
  • EV Web/FDA Web Trader Account Creation.
  • E2B R2 to R3 BFC Support.