- 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
In many parts of the world, including the European Union (EU) and United Kingdom (UK), there is a mandatory legal requirement for a Marketing Authorisation Holder (MAH) to appoint a named and experienced Qualified Person Responsible for Pharmacovigilance (QPPV) for their authorised products and those in marketing authorisation application (MAA).
Acting as the single point of contact and providing safety or any other benefit-risk evaluation responses on a 24/7 basis for Competent Authorities and MAH as required.
Establishing and maintaining a MAH’s PV system, ensuring that the information contained in the Pharmacovigilance.
System Master File (PSMF) is an accurate and up-to-date reflection of the PV system under the QPPV’s responsibility.
Overseeing the safety profiles of medicinal products, emerging safety concerns and risk minimisation measures.
Ensuring the necessary quality, including the correctness and completeness, of PV data submitted to Competent Authorities in Member States, the EMA, and the MHRA.
Oversight of Risk Management Plans (RMPs), Post-authorisation Safety Studies (PASS) and Periodic Safety Update Reports (PSURs).
Overseeing the network of Local QPPVs or Local PV Persons and local PV activities.
When selecting an outsouced services partner for your EU/UK QPPV needs, experience matters, and with iVigee you gain access to the level of experience and expertise that makes the difference when navigating the complexities of pharmacovigilance. And of course that experience is supported by our world leading global regulatory intelligence system iViReg to ensure the latest regulatory changes or other information are considered.
In addition to individual experience, thanks to our diverse team of QPPVs, we foster a dynamic exchange of expertise, creating an internal advisory network that amplifies their collective experience. This collaborative approach enables our QPPVs to support each other, offering a breadth of perspectives. This shared knowledge pool is a significant asset, ensuring more robust and multifaceted pharmacovigilance solutions for our clients.
iVigee specialises in providing QPPV personnel and support to global pharmaceutical organisations with marketed or in-application products in multiple markets. We regularly test our 24/7 availability, and all back up procedures and protocols are always in place.
We also perform a gap analysis on your current PV System to identify areas for improvement Our team takes a proactive approach, anticipatiing challenges before they arise, prepared with solutions to keep you compliant.
All our QPPVs have direct experience within Health Authorities, pharma companies, or service providers, and may offer also experience with regulatory authorities PV inspections. We are covering all regions through our sustainable network of Local PV experts. We ensure all reporting, response, and documentation is fully up to date at all times, and we can also support aggregate reporting and risk management to provide a connected pharmacovigilance solution.
Our objective is to enable organisations to establish and maintain scalable, simple, powerful, and elegant quality and pharmacovigilance systems that maintain compliance whilst focusing on patient safety, ensuring these systems can adapt and grow with their evolving needs.