Our team comprises 40 EU/UK Qualified Persons for Pharmacovigilance (QPPV) along with their deputies, alongside over 95 local contact persons responsible for PV (LCPPV). Together, they offer comprehensive assistance in establishing and managing intricate global PV systems and engaging in non-routine PV activities. With decades of industry experience and profound knowledge of industry trends and regulations, our experts deliver unparalleled expertise.

Our QPPVs offer not only oversight but also general pharmacovigilance consultancy, providing effective guidance on additional PV and risk management activities throughout your product’s lifecycle. PrimeVigilance excels in Pharmacovigilance System Master File (PSMF) and PV Safety Data Exchange Agreements (SDEA) authoring, optimization, and management, ensuring streamlined negotiations and compliance with PV Agreements (PVAs).

Throughout all phases of the PVA process—pre-PVA, creation, implementation, and maintenance/termination—our experts offer invaluable assistance, crafting practical SDEAs/PVAs and monitoring compliance to facilitate effective stakeholder negotiations and prompt amendments.

We meticulously review pharmacovigilance agreements for drug-device combination (DDC) products with suppliers, ensuring thorough consideration of additional data requirements such as device malfunctions and device-related events.

Our seasoned EU QPPVs and technical experts are adept at developing and maintaining inspection-ready PSMFs associated with authorized medicinal products, while also ensuring adherence to specific regional requirements. In Europe, any changes to the summary of PV systems or PSMFs are promptly communicated through our dedicated resources via the Article 57 database (XEVMPD).