Special Interest Groups - PV Professional Qualification Framework

PV Professional Qualification Framework

The ISoP Special Interest Group on Pharmacovigilance Professional Qualification Framework

ISoP plays a significant role in training and science of pharmacovigilance worldwide. However, we believe there is an additional critical topic where ISoP can play a key global role. There is a need of harmonization in professional pharmacovigilance qualifications, especially in the area of defying PV professional careers structures.


Most professions have such structures allowing for further specialisation, recognition, and development. The profession of pharmacovigilance does not currently have such structure that is globally recognized and accepted. This can result in:
• inconsistent performance in some parts of pharmacovigilance world
• difficulty with decision making
• substandard practices leading to unnecessary patient safety issues
• variable recognition of the pharmacovigilance profession
• confused recruiters
• people in leadership position without proper qualifications

This new SIG on Pharmacovigilance Professional Qualification Framework should build on the successes of ISoP PV curriculum, existing certification programmes and academic degrees, and should create internationally recognised qualification framework for all career walks in PV.
In ISoP we believe that Pharmacovigilance as a profession has reached a maturity that is suitable for creation of the framework now.

The SIG was officially launched in October 2017 during the 17th ISoP Annual Meeting in Liverpool.

Future steps

There is much to be done for the qualification framework, for instance:
– Defining recommended seniority levels for regulators, pharma and academia, creating “ISoP” global standard as a term of reference
– Certification programmes for technical skills (such as existing MedDRA, EudraVigilance) developed and run by ISoP.
– Board certifications for QPPVs, auditors and inspectors, run by ISoP
– International continuous education programme run by ISoP (with credits and re-certifications)


This is a call to all interested ISoP members to join this new SIG. Our group will include members from several different continents and like ISoP in general, we are truly international!
Any member of ISoP who has an interest in Education and would like to join the ISoP PV Professional Qualification Framework Group please contact Dr Jan Petracek by e-mail at: administration@isoponline.org