Why Manual Pharmacovigilance is Failing: How PvEdge® Solves Compliance & Efficiency Issues
Pharmacovigilance (PV) is essential for drug safety, yet many pharmaceutical companies still rely on outdated manual processes. With increasing global regulations from the FDA, EMA, and MHRA, manual PV workflows create serious challenges that impact compliance and efficiency.
The Problem: Why Manual Pharmacovigilance is a Risk
Pharmacovigilance teams face these major challenges:
High case volumes: Manually handling thousands of adverse event (AE) reports leads to bottlenecks and delays.
Regulatory complexity: Different regions have unique compliance requirements, increasing the risk of missed deadlines and errors.
Data inaccuracy: Manual data entry mistakes lead to compliance violations and compromised patient safety.
Inefficient signal detection: Without AI-powered insights, potential drug risks are identified too late.
The Solution: How PvEdge® Automates & Enhances Pharmacovigilance
PvEdge®, an AI-powered pharmacovigilance software by Sarjen, eliminates inefficiencies in drug safety monitoring. Here’s how:
Automated Adverse Event Reporting
PvEdge® captures, processes, and submits AE cases automatically, ensuring faster and error-free reporting with E2B(R3) compliance.
Regulatory Compliance Tracking
With built-in tracking for FDA, EMA, and MHRA requirements, PvEdge® ensures companies stay compliant and avoid regulatory penalties.
AI-Driven Signal Detection
PvEdge® detects safety signals in real-time, reducing the risk of late responses and ensuring proactive risk management.
Seamless Integration & Custom Workflows
PvEdge® integrates with existing PV systems and electronic health records (EHRs), streamlining pharmacovigilance operations.
Why Pharma Companies Must Automate Now
Failure to automate PV processes leads to compliance breaches, inefficiencies, and potential safety risks. With PvEdge®, companies can:
Reduce AE case processing time by up to 50%
Ensure error-free regulatory submissions
Strengthen drug safety monitoring
Don’t Let Manual Pharmacovigilance Put Compliance at Risk
Pharmacovigilance automation isn’t a luxury—it’s a necessity. PvEdge® transforms drug safety processes by reducing errors, ensuring compliance, and enhancing efficiency.
Ready to upgrade your PV system? Discover PvEdge® today and safeguard your pharmacovigilance workflow.
