Patient Safety (Pharmacovigilance)

Along the whole product lifecycle from phase I until post-marketing & commercialization our international team provides true end-to-end solutions for pharmacovigilance system & operation as well as benefit-risk-management services. Our global footprint enables us to cover all needs worldwide, on local affiliate level as well as for the global & headquarter functions.

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    Advice, built and operate with proven track record

    • Global Pharmacovigilance Systems
    • EU QPPV and QPPV office
    • PSMF management
    • NCP (National Contact Person)
    • Local (affiliate) PV Services
    • Local integrated Medical Information Services
    • Global and Local PV Intelligence
    • ICSR Management
    • Pharmacovigilance Scientific Data Management including global safety database
    • Scientific Literature Screening
    • Clinical Trial Safety Management
    • Benefit-Risk-Management
    • Signal Management
    • Safety Writing (PSUR / PBRER, DSUR, RMP)
    • PV Quality Systems
    • PVA Management
    • Audit and CAPA Management
    • Pharmacovigilance Consulting

    Patient Safety (Pharmacovigilance) Services

    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 […]

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    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.

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    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, […]

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    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.

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    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.

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    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.

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    If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness.

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    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.

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    Global Approach

    PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

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