Qualified Person for Pharmacovigilance (QPPV)
PharmaLex will take on the responsibilities of the EU Qualified Person Responsible for Pharmacovigilance (QPPV) according to the requirements laid down in the GVP – Module I and/or provide a deputy EU QPPV as a back-up for the EU-QPPV.
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The PharmaLex EU-QPPV is located in one of the EU/EEA PharmaLex offices and fluent in English language. The QPPV has extensive experience in establishing and maintaing the MAH’s Pharmacovigilance System including profound knowledeg and full understanding on all tasks related to Pharmacovigilance. Besides the nominated Deputy QPPV, back-up arrangements to ensure the 24/7/365 availability of the QPPV are also done via an internal QPPV call-system.
Key tasks of the EU-QPPV include
- Implementation and maintenance of a functional and compliant pharmacovigilance system;
- Ongoing monitoring of the benefit and risks of medicinal products, including overview of medicinal safety profiles and any emerging safety concerns;
- Review and oversight of the product Risk Management Plans, including any resulting risk minimization measures and any other conditions or obligations adopted as part of a marketing authorization and/or other commitments relating to safety or safe use of a medicinal product;
- Maintenance of the Pharmacovigilance System Master File
- Serving as point of contact to Regulatory Authorities with 24 hours availability, ensured via a PharmaLex QPPV call-system
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Pharmalex QPPVs have long standing working experience in all areas of PV and are part of an extended expert network of QPPVs within PharmaLex.
This network helps them to leverage the shared knowledge of best practices and implement optimal solutions for Pharmalex clients.
Based on their broad experience Pharmalex QPPVs are ready to assume responsibility and accountability for their work and the safety of medicines.
The QPPV will seamlessly integrate into the MAH’s decision making bodies and take a lead in protecting the MAH’s products and patient safety..
The PharmaLex QPPV are reliable partners in maintaining and continuously improving the MAH’s PV system. Pharmalex PV systems have a proven track records of successful inspections and audits.
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