- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
The appointment of a Qualified Person Responsible for Pharmacovigilance (QPPV) is a mandatory requirement of pharmacovigilance regulations within the EU and UK and many other countries worldwide. It is therefore an essential role for ensuring the compliance of Marketing Authorisation Holders (MAHs) and the medicinal products they have authorised in these regions.
QPPVs are responsible for an extensive list of PV activities under those regulations, and these are usually delegated, or outsourced, for organisational efficiency, thus overall management of various inputs, stakeholders, information, compliance and others may be facilitated by the QPPV office team. iVigee provides full support for these QPPV office services in close collaboration with the QPPV, ensuring all the routine and ad-hoc tasks they are responsible for are managed in a timely manner, whilst maintaing documented QPPV oversight and full regulatory compliance.
The process of QPPV and deputy appointment for a MAH.
The creation of a new full pharmacovigilance system, specifically tailored to a client’s needs.
PV Partnership management (PVAs/SDEAs).
The Management of the Pharmacovigilance System Master File (PSMF).
EudraVigilance and XEVMPD activities (e.g., PSMF registration, AMP, DMP inserts or updates)
Procedural documents (e.g., SOP, WIN) drafting, management, regular updates oversight.
Local QPPV network setup, oversight, coordination and consolidation of local input.
Monitoring of pharmacovigilance regulatory intelligence on global/regional/local levels.
Handling all Pharmacovigilance related requests from Health Authorities.
Monitoring of MA commitments, compliance monitoring.
Administrative QPPV support (mailbox management, taking meeting minutes, etc.)
Long-term audit strategy as well as annual audit program.
Pharmacovigilance auditing and Gap analysis of pharmacovigilance system for inspection readiness.
CAPA management (coordination of preparation, monitoring of due dates, support in resolution).
A medically qualified person support.
The preparation and delivery of targeted PV training for both experienced and non-experienced personnel.
Our team of QPPVs and support staff have the experience and expertise to provide a full QPPV office service. We are able to overcome all your operational challenges and meet all your expectations with our structured pharmacovigilance system and maintenance approach.
We combine that deep PV knowledge with our innovative IT technologies such as iViReg, iViSight or iViMedic to maximise efficiency and ensure optimal compliance wherever you need it.
With iVigee, clients gain a partner committed to sustainable practices, ensuring long-term compliance with expert pharmacovigilance management and support.