Pharmacovigilance Systems and Processes Standards

Project Charter

The goal of the Pharmacovigilance Systems and Processes Standards (PS²) program is to establish a set of standard solution requirements for pharmacovigilance systems, starting with Case Intake in 2025 via the PS² – Case intake project, to avoid replication of effort during solution selection and implementation and foster innovation.

Challenge

The pharmacovigilance (PV) software solutions lack interoperability, making it difficult for Marketing Authorization Holders (MAHs) to adopt best-of-breed solutions. Although PV system requirements are broadly similar across organizations, each MAH independently defines specifications for procurement and implementation, driving up costs and complexity for both buyers and vendors. Existing solutions rarely cover the full spectrum of PV needs comprehensively, and the absence of integration standards leads to widespread customization. As a result, innovation and automation are stifled by the significant effort required to establish foundational capabilities and ensure compatibility with legacy systems.

Solution

The PS² – Case Intake project aims at establishing common Case Intake solution requirements and interoperability standards and a corresponding logical data model and data dictionary. In addition, the project will establish an operational approach to sustain those standards and certify software solutions against them. This will be achieved by working with MAHs as well as suppliers.

Benefits

For sponsors:

Lower costs: Standard requirements re-used across sponsor companies, less customizations
Easier and faster solution evaluation via certification process
More innovation: Ability to integrate best-in-class solutions, PV resources focused on innovation, vendors incentivized to differentiate through innovation

For suppliers:

Lower costs: Answers to RFPs for standard requirements can be re-used, no need to elicit standard requirements
Higher requirements maturity: Standard requirements will have been vetted across sponsors and are less variable

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Project Manager

Marc Graber

Marc Graber is the founder and managing director of PharmaVMG GmbH and specializes in helping pharmacovigilance (PV) teams define their technology strategies and implement related solutions. Marc is a software engineer by training and has over 30 years of experience in IT consulting, project and program management and business partnering. He worked for 17 years supporting PV as a project/program manager and business partner at Novartis and was leading the Novartis IT Safety team for 7 years. Marc is now leading the Pharmacovigilance Systems and Process Standards (PS2) - Case Intake project at Pistoia Alliance.

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