Defining the competencies of those conducting pharmacovigilance.

Medical Services, PAREXEL International Ltd., Uxbridge, Middlesex, UK.

PURPOSE: The absence of agreed competencies in pharmacovigilance and patient risk management is a key factor hindering the development of training and a curriculum in these interrelated disciplines. If competencies were to be developed, they could be tailored to the different roles and responsibilities of the various staff involved. PROPOSAL: We describe a simple theoretical model of functional and behavioural competencies that is based on an organisation with three levels of staff: evidence collectors and gatherers, evidence processors and distillers, and decision makers. CONCLUSIONS: To stimulate discussion about how to enhance the progress already being made in pharmacovigilance and patient risk management, we have proposed functional and behavioural competencies for pharmacovigilance as a way of identifying and measuring scientific and personal skills pertinent to pharmacovigilance. Competencies should, we believe, be agreed and adopted by all those seeking to improve pharmacovigilance. We invite discussion of these proposals.

PMID: 16184620 [PubMed - indexed for MEDLINE]