Welcome to the PV Health Index Survey

Fiore Healthcare Advisors has provided the "PV Health Index" survey to help you determine the overall state of your pharmacovigilance health. Each of the following survey statements are followed by five possible selections from "strongly disagree" to "strongly agree." We encourage you to answer to the best of your ability in order to understand your PV Health.

 

Please note, the statements and survey results here are only representative of your overall PV Health, and are not to be used as evidential or conclusive. For a professional and complete audit of your PV Health, please contact us today to schedule a time to speak.

Click "Next" to begin the survey.

People Icon


Our PV team is appropriately resourced with medical and operational leadership, expertise and skills in the right positions
We are confident that our current PV team configuration and sourcing mix is structured appropriately for the number of compounds in development/marketed
We know how our Pharmacovigilance team needs to be structured two to five years from today and we have the PV infrastructure in place to scale for growth
Process Icon


All our internal PV department processes have been mapped and have been adequately characterized and documented
Health authority reporting processes are in place and are adequate
We have an SOP review and approval process in place with strong collaboration from cross-functional teams (QA etc)
Technology Icon


Our Safety Database fulfills the required standards, is validated and compliant and is built for current and future needs
We have properly assessed our Safety Database’s configuration and coding to ensure it is robust enough to fulfill our PV needs
Our safety data base has the appropriate outputs in order to perform robust safety analysis and signaling for our products
Governance Icon


We have written procedures for issue escalation that can be easily understood for all involved stakeholders and for Health Authority purposes
We have safety governance charters in place outlining the goals, responsibilities, membership, and agreements involved in safety issues and escalation
We have a robust corporate safety governance structure in place to ensure proper safety decision making
Quality Icon


We have developed safety documents (SOP’s, WI), compliance metrics, training, and oversight
We have a robust safety quality management system in place focused on compliance and performance
We are confident that we are “PV Inspection Ready”
Product Icon


We have a complete understanding of the safety profile of our products
We have performed a comprehensive review and analysis of aggregate reports to determine and characterize the risk-benefit profile of our drug
We perform signaling and risk management activities to continually monitor the safety profile of our products