What is Pharmacovigilance (PV)? | HCLTech

Technology Q&A

Pharmacovigilance/Drug Safety
What is Pharmacovigilance (PV)?

Pharmacovigilance (PV) is the process of detecting and monitoring adverse drug reactions (ADR), adverse events (ADE), detecting potential 'signals' throughout the drug/medical device lifecycle, and also tracking trends in consumers' sentiments regarding a particular product (drug/medical device) over time. The longitudinal objective behind monitoring this is to be able to continually monitor and improve an existing product's risk/benefit balance and better manage the risk from new products. Typical activities within a pharmacovigilance process or workflow are as follows:

  1. ADR detection, collection, follow-up and reporting via PV call centers from consumers and healthcare professionals: Frontend Processes
  2. Social Media Monitoring
  3. Case Intake, Processing, Signal Management: Backend Operations

Current imperatives within the pharmacovigilance process/pharmacovigilance plan across organizations

  • Improve quality and regulatory compliance while reducing cost and streamlining processes across the PV conundrum
  • Increase variety of data sources (a big data healthcare problem)
  • Simplify case intake and processing by leveraging mobile and digital technologies (making it faster, and more efficient and cost effective)
  • Active monitoring and real time signal detection

How the market is evolving in terms of technology

  • Aging technology stack with multiple COTS products with varied complexities and limited interoperable capabilities
  • Ever changing regulatory landscape which demands that the technology systems to be upgraded adhere to new requirements
  • Focus of current systems now shifting from just data capture and collection to providing meaningful insights
  • Renewed focus on collaboration across different stakeholders - between internal teams, PV teams, and external stakeholders, for extracting further valuable insights on safety
  • Real-time data mining to find emergency safety signals
  • Key Pharmacovigilance/Drug Safety COTS Product Vendors include Oracle ARGUS, Oracle AERS, ARISg, Oracle Empirica Signal, SAS, EXTEDO's PcVmanager (PV Management), PvNET- Pharmacovigilance Software and Drug Safety Database (Sarjen), etc