Pharmaceutical & BioTech

Within the European Union (EU) or the wider European Economic Area (EEA), the role of a Qualified Person for Pharmacovigilance (QPPV) is essential.

The QPPV is responsible for establishing and managing the pharmacovigilance system of a Marketing Authorization Holder (MAH), which plays a crucial role in the underlying quality system, product safety issues, and all other pharmacovigilance and safety activities. QPPVs are officially registered in the EU’s EudraVigilance database.

Key activities of a QPPV include:

• Serving as the primary contact and providing safety or benefit-risk evaluation responses to EU national Competent Authorities or the EMA on a 24/7 basis.
• Ensuring the Pharmacovigilance System Master File (PSMF) is always up-to-date and accurately describes the current pharmacovigilance system.
• Overseeing the safety profiles of marketed products and addressing emerging safety concerns.
• Ensuring that all pharmacovigilance activities and document submissions comply with GVP practices and applicable legal requirements.
• Acting as a point of contact for PV audits or inspections.
• Maintaining detailed records of suspected adverse reactions to products.
• Drafting and submitting Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to national Competent Authorities and/or the EMA.

Outsourcing QPPV services is particularly beneficial for MAAs where an in-house QPPV is not available, as it optimizes resource efficiencies during the approval phase.

RPN offers guidance and operational execution support through all the necessary Pharmacovigilance (PV) activities and QPPV requirements at every stage of the product life cycle and whether it involves implementing a new PV system or transferring from an in-house PV department or a previous PV provider.

RPN also provides support for Local Persons for Pharmacovigilance (LPPV) at the country level, depending on applicable regulations.