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.
Contact our specialists to tailor a service plan
EU QPPV / National QPPV
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
We offer global solutions covering the entire product lifecycle
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.
Experience within a network of experts
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.
Decision making in the best interest of the MAH and patient safety
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.
Clinical Trials Adverse Event Processing
Clinical trials play a crucial part in any drug development life cycle where it is key to gain information on a product’s safety profile. The PharmaLex international team of clinical safety experts, with large expierence in the management of clinical safety activities, effectively supports sponsors with Pharmacovigilance activities during clinical trial development programmes. PharmaLex designs …More Info
Gap Analysis and Consulting
Place your Pharmacovigilance, Epidemiology, Risk management (PER) and Document Management activities in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire processes – our knowledgeable experts will be there for you no matter where you are. Expertise extends to Clinical document management (e.g. TMFs) and Regulatory document management (e.g. submissions, RIM, xEVMPD, IDMP) through one of the PharmaLex family of companies.More Info
The collection and processing of ICSRs are the most basic and important aspects of Pharmacovigilance system. PharmaLex delivers end-to-end ICSR Management solutions through our experts and services. Contact our specialists to tailor a service plan Contact Us ICSR (Individual Safety Case Report) Management PharmaLex offer the full range of ICSR Management Services from collection, triage, …More Info
We offer a modular, end-to-end approach to literature surveillance for pharmacovigilance and our experts are flexible enough to offer a tailored solution as well accordingly to client’s requirement.More Info
Monitoring and Signal Detection
PharmaLex customizes the signal management activities as per client requirements ensuring reliable, high quality, trackable data in compliance with the regulatory guidelines (e.g., GVP Module IX & FDA Good Pharmacovigilance Practice and Pharmacoepidemiologic Assessment). In addition to Signal management services, our team of experts are also experienced and well versed in providing responses to safety questions from the Health authorities by providing strategic advice on the approach to respond to the HA query; evaluating and critically appraising ICSRs, aggregate data, and literature and thereby providing a comprehensive evaluation report considering the strengths and weaknesses of all the data sets and sources reviewed.More Info
PharmaLex’s organization ensures global delivery of all PV audit services. We are the first-choice provider of PV audit services for many pharmaceutical companies around the world. At PharmaLex, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.More Info
Complete this form to stay in contact with us.
PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.