SKILLPHARMA
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Post Marketing Vigilance

Each health sector company must guarantee the safety of its products on the market and have effective vigilance systems monitoring the safety of medicinal products and early detecting any change to their risk-benefit ratio for the population

Thanks to a highly specialized and skilled team, SKILLPHARMA is the ideal Partner for the effective management of its Customers Post Marketing Vigilance Systems, as if they need the complete outsourcing of the activities, as for specific processes related to post marketing requirements. Our prime aim is to provide solutions customised to every single project and in accordance with the current legislation, without neglecting the needs of flexibility and reducing business costs

Our services include:

Pharmacovigilance

  • Provision of Qualified Person for Pharmacovigilance (QPPV and QPPV deputy) properly registered in the National Network of Pharmacovigilance (RNF) and in possession of the ICSRs and XEVMPD EudraVigilance Certificates, which is mandatory for the management of Eudravigilance activities
  • Pharmacovigilance systems management:
    • ICSR assessment, triage and processing, as well as follow-up requests (RNF and Eudravigilance)
    • Weekly worldwide and local literature search and review
    • Development and management of the Pharmacovigilance System Master File (PSMF) by using a dedicated software
    • Preparation and/or update of the Standard Operating Procedures (SOP)
    • Preparation, handling, assessment and forwarding of Periodic Safety Update Reports (PSUR) & Risk Management Plans
    • eXtended EudraVigilance Medicinal Product Dictionary
    • Continuous monitoring of the product safety profile, providing proper assessment of the benefit /risk balance
    • Planning and execution of pharmacovigilance training
    • support the medical division of the customer company in the clinical review of safety data
    • verify the implementation of possible safety changes in the products' SPC/PL, in collaboration with Regulatory Affairs Area
    • quick and thorough answers to the safety requests coming from Health Authorities, healthcare professionals and consumers
    • SDEA redaction
    • Safety Database
      We use standard fully validated safety database (SafetyDrugs®) which is E2B and 21 CFR Part 11 compliant, to produce and manage ICSRs, line-listings, annual safety reports and periodic safety update reports
    • Audit & Due diligence
      • due diligence inspection to assess the completeness and accuracy of the pharmacovigilance documents, in case the marketing authorization transfer
      • independent Pharmacovigilance systems audits of MAHs', or delegated service providers' and advice on process improvements
      • CAPA management and findings closure, also following Health Authorities inspections
      • support for organization and management of Health Authorities inspections
      The Auditor staff are RQA members

    Medical Device Vigilance Service

    • preparation and/or update of Standard Operating Procedures (SOP)
    • collaboration for the management of incidents, near-accidents and claims about medical devices detection
    • development of incident reporting to be submitted to the evaluation of the Health Authorities
    • collaboration for the investigations about incidents and for the management of the Field Safety Correction Action (FSCA)
    • development of security alerts (FSN- Field Safety Notice) ensuring their diffusion
    • Trend Report arrangement
    • follow up and/or final report management
    • collection of reports of misuse or abuse of the device
    • contact point with the Notified Body about problems emerged after the device commercialization, that can affect the certification
    • quick and thorough answers to the safety requests coming from health practitioners, consumers and competent authorities
    • arrangement and management of device vigilance trainings

    Cosmetovigilance Service

    • evaluation and management of adverse reactions, causality assessment
    • anomalies and claims management
    • notifications and SUE submission
    • SUE data assessment, corrective actions management, including notes to the market
    • Development and updating of Safety Report
    • marketing trend assessment and SUE signal detection