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Pv

Pharmacovigilance

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    • Management of spontaneous notifications (patients, health care professionals, National centers of pharmacovigilance, …) and solicited (clinital trials, Patient Support Programs…) cases of pharmacovigilance, cosmetovigilance and devices
Voir plus
– Case receipt and documentation
– Validity and seriousness assessment of PV cases
– Case entry and MedDRA coding of events or incidents in the dedicated database (Safety Easy, ARISg, Argus, etc.)
– Case assessment (WHO-UMC classification, French imputability method, imputability method for cosmetic products, etc.) and expectedness.
– Case (SARs, SUSARs, SUEs, etc.) or incidents submission to the competent authorities (ANSM, EMA via Eudravigilance, etc.) in compliance with regulatory deadlines
    • Communication with Health Authorities
Voir plus
– Provide appropriate responses to the Health Authorities and collect the necessary additional information
– Participation in surveys
– Drafting of ad hoc reports and investigation reports at the request of the Health Authorities
    • Scientific and regulatory monitoring
Voir plus
– Monitor scientific and medical literature on electronic databases (Medline, Embase, Excerpta Medica, etc.) and on all non-indexed journals
– Follow the evolution of French and international regulations on the field of activity of the company
    • Writing safety reports
Voir plus
Pharmacovigilance
– PSUR/ PBRER: Periodic Safety Update Report / Periodic benefit-risk evaluation report
– ACO & CES: Addendum to the Clinical Overview & Clinical Expert Statement
– DSUR: Development Safety Update Report
– RMP: Risk management plan
– SER: Safety Evaluation Report
Cosmétovigilance
– CPSR: Cosmetic Product Safety Report
Device vigilance
– FSN: Field Safety Notice
– PSR: Manufacturer’s Periodic Summary Report
    • Signal management
Voir plus
– Signal detection (qualitative and quantitative analysis – revision of ICSRs and statistical analysis in databases)
– Validation and evaluation of signals identified during vigilances activities
– Definition of possible measures to minimize the risks associated with the signals
– Immediately communication to the authorities of signals that may have repercussions on public health and related to the benefit-risk profile of the products in question.

    • Vigilant quality system management
Voir plus
– Quality control on pharmacovigilance activities in compliance with SOPs, GVPs and local regulations
– Implementation and monitoring of quality indicators related to the deadlines for submitting cases and periodic reports
– Ensure the initial and continuous training of employees
– Writing and updating procedures, operating modes, technical manuals and technical sheets
– Preparation and participation in inspections and audits
– Follow-up of the inspection report and implementation of corrective or preventive actions (CAPA)
– Update and maintenance of the PSMF
– Follow-up of Safety Data Exchange Agreements (SDEAs)
    • Medical Information
Voir plus
– Answer questions from healthcare professionals and patients
– Inform healthcare professionals and patients of all changes in the safety profile of products and the precautions or restrictions for use
– Promoting the proper use of medicines and medical devices with healthcare professionals and patients
– Management and follow-up of cases related to Medical Information issues
– Interface with other laboratory departments (Quality Assurance, Sales, Legal, Regulatory Affairs, Medical Service, Marketing, etc.) and subcontractors
    • Crisis management
Voir plus
– Premises equipped with 2000 m2 certified by the ISO 27001 standard
– Control of large call volumes
– Business Continuity Management (BCM)
– Experts in crisis communication
– Dedicated project manager
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