ISoP and IPV Standards

Institute of Pharmacovigilance is developing
standards for pharmacovigilance professionals. These describe Career and Competence framework and will be available soon.

 

Framework

Public Consultation

Following documents are currently in the development. Please, have a look and submit your comments via email.

 

Stage of Development

Global Professional Pharmacovigilance Certification (GPPC)

There are three main components of the GPPC.

Career Framework

Career Framework defines roles and seniority steps in pharmacovigilance profession. This describes our essential understanding of what types of jobs and career ladders are there in the industry, universities, and regulatory authorities, that one can consider for their career development.

Competence Framework

Defines the required knowledge, skills and attitudes expected for the positions defined in the Career Framework. 

This informs all education and training providers, as well as the members of the profession and candidates for certification about what competence they need to achieve to improve what they do and elevate their career.

Professional Certifcation

Professional Certification is testing competence of candidates against the expectations defined in the first two steps above. Candidates may apply for a certification in particular role and seniority step. They would be required to submit documentation to satisfy admission criteria, then pass the specific test, behavioral interview and oral exam.

Successful candidates will receive the certificate. Certificate holders would be required to ensure they keep their competent current, and potentially subject to regular re-certification, or even better, progress to the certification of the next seniority level.  

Current Workplan

 

Career Framework

  • Definition of roles and seniority in pharmacovigilance career
  • October 2021 (version 1)
  • Publication in 3Q 2021

Competence Framework

  • Definition of required knowledge, skills and attitudes for a role and seniority
  • December 2021 (1st role standard)
  • Publication 4Q 2021

Professional Certification

  • Testing Competence of candidates for a particular role and seniority
  • December 2021 (Pilot)
  • 1Q 2022 - 1st role standard and seniority certification in production
  • 4Q 2022 - all defined roles and seniorities certifications in production

Timeline

2015
Work with ISoP board

Delivery of the first educational courses in Pharmacovigilance

2018
Work with ISoP board

Start of the collaboration with the ISoP SIG on Career Framework in Pharmacovigilance

2020
Work with ISoP board

Organisation of the first common seminar with ISoP, called ISoP Prague Seminar

2021
Work with ISoP board

Work with ISoP Advisory Board and Executive Committee on preparatory work of Global Pharmacovigilance Professional Certification (GPPC) program

April 2021
Work with ISoP board

Selection of Web Design partners and exploratory talks with certification providers

May 2021
Work with ISoP board

First role and seniority survey launched

May 2021
Work with ISoP board

Collection of the test questions launched

May 2021
Work with ISoP board

ISoP Strategy and Concept paper regarding GPPC approved for ISoP membership consultation

May 2021
Work with ISoP board

Terms of Reference for Scientific Board approved by the Executive Committee for ISoP membership consultation

July 2021
Work with ISoP board

First draft guideline for Career Framework published for consultation

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