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