DIA Safety and Pharmacovigilance Certificate Program is a competency-based program. This comprehensive program is based on the DIA Safety and Pharmacovigilance Competency Framework developed with experts working in the field. These competencies outline the functional knowledge and skills needed to work in safety and pharmacovigilance and comply with US and EU regulations. The Certificate Program is designed for individuals new to the field, for those with one to three years of experience, or for those looking to broaden their expertise in this area. The purpose of the program is to provide the knowledge and skills safety professionals need to succeed in their role, as well as to provide a learning pathway that allows individuals to further develop and advance their career. The safety competencies may also be leveraged by leaders in the industry to help build safety teams and develop their employees.
Enrollment in the Certificate Program is free. After enrolling, participants can track their progress in the Learning Path through the DIA Learning Management System (LMS). DIA developed a comprehensive training curriculum and defined a Learning Path, based on this competency framework, which participants can acquire the knowledge and skills through attendance at live training courses, as well as online and blended learning courses. After a participant has completed the required 19 Core and Elective Track credits, they must pass an exam, with a score of 75% or better, designed to measure achievement of these competencies to complete their Learning Path.
Participants will earn digital credentials as they continue along the Learning Path, ultimately culminating in the granting of the DIA Safety and Pharmacovigilance Certificate and corresponding digital credential. The certificate term is for life.
“This program is a wonderful primer on all relevant aspects of pharmacovigilance – it will be a good program for individuals entering the field, as well as helping to broaden an individuals knowledge who may have only been focused on a single aspect of pharmacovigilance to date. This program will also help regulators ensure their staff are fully knowledgeable on good pharmacovigilance practices and relevant regulations thereby easing their burden of upskilling staff. The program is also a great tool to demonstrate staff are properly trained to work in pharmacovigilance which could help with inspections.”
“This is a comprehensive program that covers much of what you need to know if you plan to work in pharmacovigilance. It is a streamlined approach rather than trying to gather all the information independently. It provides evidence that the participant has successfully completed knowledge transfer.
“This program is characterized by its completeness covering all aspects of drug safety in the US and Europe from phase 1 to post-marketing explained by experts. This includes the methods to prepare ICSRs with the relevant data, to write concise safety updates, to detect and manage signals, as well as to manage and minimize the risks in total respect of the legislation and the latest scientific developments.”
“An educated, comprehensive, and experienced safety team is a vital component for any organization moving forward, particularly as regulators not only require safety data throughout the lifecycle of a product, but have a thirst in acquiring safety data from a multitude of sources. Knowing how to navigate all of this will be obtained in DIA’s Safety and Pharmacovigilance Certificate Program.”