Drug Safety Monitoring

InFlow-PV Pharmacovigilance

Comprehensive solutions for adverse event reporting and regulatory compliance.

Pharmacovigilance Overview

What is InFlow-PV?

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

The goal of InFlow-PV is to improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.

With increasing regulatory scrutiny, pharmaceutical companies need robust PV systems. InFlow-PV provides a complete framework to manage safety data effectively.

PV Activities Covered

InFlow-PV supports end-to-end PV activities with documented procedures:

  • Case Reception: Centralized intake of adverse event reports from various sources.
  • Case Validation: Preliminary assessment to ensure minimum reporting criteria.
  • Safety Data Entry: Structured data entry compliant with regulatory standards (E2B).
  • Quality Control: Ensuring accuracy and completeness of case data.
  • Medical Review: Assessment of causality and severity by medical professionals.
  • Reporting: Generation of expedited reports (ICSRs) and aggregate reports (PSURs/PBRERs).
PV Workflow Diagram
Why InFlow-PV?

Benefits of InFlow-PV Monitoring System


Regulatory Compliance

Ensure full compliance with global regulations (FDA, EMA, WHO) for drug safety reporting.

Operational Efficiency

Automated workflows reduce manual effort and processing time for individual case safety reports.

Data Integrity

Maintain consistent and high-quality safety data with built-in validation checks and audit trails.

Cost Savings

Reduce compliance costs through streamlined processes and reduced risk of penalties.

Ensure Drug Safety Today

Implement a robust Pharmacovigilance system with InFlow-PV.