The QPPV function plays a pivotal role in ensuring the continuous and compliant operation of a sponsor's pharmacovigilance (PV) system. The QPPV office maintains end-to-end oversight of the PV framework, ensuring regulatory compliance, operational continuity, and ongoing evaluation of the benefit-risk profile of medicinal products.
Serving as the 24/7 single point of contact for competent authorities, the QPPV is supported by a designated Backup QPPV to ensure uninterrupted coverage at all times. Together, they oversee PV system performance and ensure that safety concerns are promptly identified, assessed, and addressed to safeguard patient well-being.
Core QPPV Responsibilities
- Defining, implementing, and maintaining a compliant pharmacovigilance system
- Providing strategic oversight and governance of PV processes and controls
- Acting as the primary liaison with competent authorities during safety-related issues
- Proactively engaging with sponsors on emerging risks and safety signals
- Delivering periodic feedback and insights on PV system performance and compliance
- Overseeing implementation of AI/ML tools and ensuring human-in-the-loop decision-making in automated safety processes
Global QPPV Coverage
CareLyft offers experienced UK and EU QPPV services, delivered by senior pharmacovigilance professionals based in the UK and Croatia. Our structure includes clearly segregated roles:
- UK-QPPV and UK-Backup QPPV
- EU-QPPV and EU-Backup QPPV
This model ensures full alignment with MHRA and EMA regulatory expectations. Additionally, we provide a dedicated Responsible Person for EudraVigilance (RPEV) to support EU clinical trial safety reporting obligations.
Local QPPV & National Contact Person Services
Certain jurisdictions require the appointment of a Local QPPV or National Contact Person for Pharmacovigilance (NCPP) in addition to the global QPPV. CareLyft supports these requirements through a strong network of trusted local partners across 35+ countries, enabling seamless regional and country-specific compliance.
For UK-based requirements, we also offer a National Contact Person service as an alternative to appointing a separate UK QPPV, depending on client preference and regulatory strategy.