Competency
Standards

In partnership with the International Society of Pharmacovigilance (ISoP), the Institute of Pharmacovigilance is developing global competency standards for a wide range of pharmacovigilance roles. Each standard defines the required knowledge, skills, and attitudes expected from a specific PV role.

PV Career Framework

Together with the ISoP Special Interest Group ‘PV Professional Qualification Framework’, Institute of Pharmacovigilance is developing Career Framework to describe what roles, types of jobs and career ladders there are in the industry, universities, and regulatory authorities, that one can consider for their career development. 
Below, you will find the latest working version:

PV Career Framework

 

Global Competency Standards

In partnership with International Society of Pharmacovigilance (ISoP) and building on the PV Career Framework, the Institute of Pharmacovigilance is developing competency standards for a wide range of pharmacovigilance roles. Each standard defines the required knowledge, skills, and attitudes expected from a specific PV role.
Below, you will find all the currently published competency standards:

Pharmacovigilance Awareness for Healthcare Professionals

Public Consultations

Following documents are currently in the development and we always welcome your comments and input. Please, have a look and submit your comments via email to info@pharmacovigilance.institute 

Thank you for your contribution to the pharmacovigilance profession!

Stages of Development

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 Certification

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 competency 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
  • September 2021 (draft version)
  • Publication in Q2 2023

Competence Framework

  • Definition of required knowledge, skills and attitudes for a role and seniority
  • June 2022 (1st role standard produced)
  • 2023 - standards for additional 10+ roles under development

Professional Certification

  • Testing Competence of candidates for a particular role and seniority
  • June 2022 - Pilot PV Awareness certification
  • April 2023 - Official launch of PV Awareness certification
  • August 2023 - First role-based certification available