Role of Qualified Person for Pharmacovigilance (QPPV)

Marketing authorisation holders must appoint a permanently available EU qualified person responsible for pharmacovigilance (QPPV) with defined duties and contact details, and oversee the pharmacovigilance system master file.

Define the qualifications for the EU QPPV, including theoretical and practical pharmacovigilance knowledge, multidisciplinary expertise in medicine, pharmaceutical sciences, epidemiology and biostatistics, and medical training or access to medical professionals.

The EU qppv oversees the marketing authorisation holder's pharmacovigilance system, ensuring 24/7 availability, backup coverage, and authority to improve safety, data quality, and regulatory compliance.

learn the role and responsibilities of local QPPV, the national person responsible for pharmacovigilance, and which EU countries require nomination at national level.

Understand the pharmacovigilance officer in charge in India, who manages adverse drug reaction reports, develops training modules, frames SOPs, maintains the quality management system, and handles regulatory authority inquiries.

Complete the course, retrieve your completion certificate from your profile, and share it on LinkedIn; access downloadable materials, Q&A support, and explore related pharmacovigilance courses for QPPV roles.