The QPPV office oversees the implementation and management of the pharmacovigilance (PV) system, ensuring its smooth operation and maintaining end-to-end oversight for the sponsor. Acting as the 24-hour contact point for competent authorities, the QPPV is supported by a backup QPPV to cover any absences. Together, they ensure the effective functioning of the PV system and monitor the risk-benefit balance of medicinal products to guarantee their safe use.

Defining the process requirements to maintain a compliant pharmacovigilance system.

Engaging with clients and competent authorities in the event of emerging safety issues or concerns.

Providing regular feedback to clients on key elements of the pharmacovigilance system.

Our team of experienced QPPVs, based in the UK and Croatia, includes separate roles such as UK-QPPV/UK-Backup QPPV and EU-QPPV/EU-Backup QPPV, ensuring full compliance with both UK and EU regulatory requirements. We also have a dedicated Responsible Person for EudraVigilance, supporting clinical trials in the EU.

Depending on the local regulatory requirements, certain countries may mandate a local contact person or a locally qualified individual in addition to the QPPV. We have a robust network of strategic local partners across over 35 countries and actively serve various clients worldwide. This includes providing a National Contact Person service in the UK, should clients prefer this over appointing a separate UK QPPV.

SentinelRX offers expert guidance on the different roles and responsibilities of QPPVs and local QPPVs. We provide tailored services that ensure compliance with the unique pharmacovigilance regulations specific to each country.