Special Interest Groups - PV Professional Qualification Framework

PV Professional Qualification Framework

The ISoP Special Interest Group on Pharmacovigilance Professional Qualification Framework

ISoP through its mission plays a pivotal role in pharmacovigilance worldwide. The quality of pharmacovigilance work depends primarily on the competence of people performing pharmacovigilance tasks.

Building on a number of activities in the past aimed at improving pharmacovigilance training, including the ISoP Curriculum, the SIG’s goal is to create clear definitions of competences and career paths of pharmacovigilance professionals.

Background

Most professions have structures allowing for further specialisation, recognition, and development; however, the profession of pharmacovigilance does not currently have a globally recognized career structure. This may result in:

• inconsistent performance in some parts of pharmacovigilance world
• inefficient and potentially erroneous decision making
• substandard practices that may endanger patient safety
• variable recognition of the pharmacovigilance profession
• confused recruiters

The SIG on Pharmacovigilance Professional Qualification Framework should build on the successes of the ISoP PV curriculum, existing certification programmes and academic degrees, in order to ultimately create an internationally recognised qualification framework for all career walks in PV.

In ISoP, we believe that Pharmacovigilance as a profession has reached its maturity and now is a suitable moment for creation of the framework.

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

Qualification Framework

In cooperation with the Institute of Pharmacovigilance (IPV), the SIG has been working on defining recommended seniority levels and competencies for regulators, pharma industry, and academia, creating an “ISoP” global standard for qualifications as a term of reference.

Global Pharmacovigilance Professional Certification

ISoP SIG and IPV have been jointly working on the development of Global Pharmacovigilance Professional Certification program (GPPC), which is planned to be launched in April 2022.

GPPC is managed by IPV and will be testing candidates’ competences (knowledge, skills, and attitudes) against the competency guidelines created by ISoP SIG.

The newly formed ISoP Scientific Board will supervise all certification programs, supported by Examination Boards at regional levels, while closely collaborating with ISoP Chapters, pharmacovigilance expert network and volunteers worldwide.

Future steps

As the pharmacovigilance profession is ever-evolving, we will be updating the career frameworks and competency guidelines on an ongoing basis.

The GPPC program will be eventually deployed globally in many language mutations.

Membership

All interested ISoP members may join this SIG and volunteer their time and expertise to contribute to this exciting project.

Any member of ISoP who has an interest in Education and would like to join the ISoP PV Professional Qualification Framework Group, please contact ISoP by e-mail at administration@isoponline.org