I.B.7. Training of personnel for pharmacovigilance

Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes by an organisation is intrinsically linked with the availability of a sufficient number of competent and appropriately qualified and trained personnel (see I.B.6.).

All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)]. For marketing authorisation holders, this training shall relate to the roles and responsibilities of the personnel [IR Art 10(3)].

The organisation shall keep training plans and records for documenting, maintaining and developing the competences of personnel [IR Art 10(3), Art 14(2)]. Training plans should be based on training needs assessment and should be subject to monitoring.

The training should support continuous improvement of relevant skills, the application of scientific progress and professional development and ensure that staff members have the appropriate qualifications, understanding of relevant pharmacovigilance requirements as well as experience for the assigned tasks and responsibilities. All staff members of the organisation should receive and be able to seek information about what to do if they become aware of a safety concern.

There should be a process in place within the organisation to check that training results in the appropriate levels of understanding and conduct of pharmacovigilance activities for the assigned tasks and responsibilities, or to identify unmet training needs, in line with professional development plans agreed for the organisations as well as the individual staff members.

Adequate training should also be considered by the organisation for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance. Such activities include but are not limited to those related to clinical trials, technical product complaints, medical information, terminologies, sales and marketing, regulatory affairs, legal affairs and audits.

Appropriate instructions on the processes to be used in case of urgency, including business continuity (see I.B.11.3.), shall be provided by the organisation to their personnel [IR Art 10(4), Art 14(3)]