Key Resources


Given the wide variety of global regulatory requirements, managing the volume, variety and velocity of pharmacovigilance data presents a significant challenge. Operations that are repetitive in nature and of relatively low business value are ripe for automation to gain efficiencies and reduce costs.

The Intelligent Automation Opportunities in Pharmacovigilance Initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes. By conducting an impact assessment and working with global health authorities to verify risks/issues with their use, this initiative will provide guidance, as appropriate, on applications of new technology in Pharmacovigilance practice.



  • Enhanced speed through automation
  • Greater consistency within a particular sponsor company’s case processing and reporting while limiting errors commonly associated with manual data processing
  • More efficient allocation of resources to address more immediate priorities


  • A catalyst for third-party innovation in intelligent automation

Available Assets

The Initiative assets below are currently available:

  • Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities: This published paper helps facilitate understanding of intelligent automation technology-related terms in the PV context and presents overall challenges and opportunities for PV
  • Interactive ICSR and Automation Technologies Tool (IATT): The online tool and published paper will provide an understanding of where opportunities for intelligent automation are in the ICSR process and the level and type of benefits that could be achieved
  • 2020 Technology Matrix: Provides information regarding the types of technologies available in pharmacovigilance and maps the level of implementation of each technology to the Individual Case Safety Report (ICSR) process

The following asset is in development for 2020:

  • Guidance for Validation of Automated Pharmacovigilance Systems: This position paper will provide considerations to the industry on validation strategies being utilized and is intended to facilitate dialogue with Health Authorities on this topic


Similar Initiatives

Value of Safety Information Data Sources


Interpretation of Guidances & Regulations


Advancing Safety Analytics