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Severine DurierSD

Severine Durier

Medical affairs/Clinical affairs Consultant

1 032 €/jour
Dubai, AE
15 ans et +

Délai de réponse moyen : 1h

À propos de Severine

I am a French independent consultant based in Dubai specialized in Medical and Clinical Affairs for Medical Devices and Pharmaceuticals companies. Pharmacist by training, I am passionate about Science! I have been working in Pharmaceuticals and Medical devices industry for the past 20 years with expertise in International Clinical trials, Medical affairs and CRO management. Main fields of expertise are cardiovascular, ophthalmology (drugs and devices), orthopedics and more recently Aesthetics but I can work in any medical area. I do offer various services that include but are not limited to training and workshop, medical congress coverage, Advisory Board organization and report, site assessment for clinical studies, medical writing…
  • Français

    Bilingue ou natif

  • Anglais

    Capacité professionnelle complète

  • Espagnol

    Capacité professionnelle limitée

  • Allemand

    Notions

Accepte de travailler sur site
Dubai (jusqu’à 50 km)

Expériences

  • BioSciences GmbH
    Vice-President, Medical and Regulatory Affairs
    SECTEUR MÉDICAL
    octobre 2022 - janvier 2024 (1 an et 3 mois)
    Dubai, Émirats arabes unis
    - In charge of planning and execution of Medical and Regulatory Strategies
    - Responsible for Medical Information and Communication, Training and Clinical evidence generation
    - Overseeing registration process world wide (EU, LATAM, Middle East, Africa, Asia, Australia
    - In charge of coordination of CER writing
    Medical Information Planning CRO managment Project Management Team Leadership
  • Eclevar MedTech
    Consultant
    SECTEUR MÉDICAL
    octobre 2019 - octobre 2020 (1 an)
    Paris, France
    - Accompagnement d’entreprises de dispositifs médicaux (classes I, II, III) dans la conformité MDR, incluant l’élaboration et la revue des plans PMCF et des rapports d’évaluation clinique.
    - Collaboration avec les équipes pour garantir la précision documentaire et le respect réglementaire.
    - Résultats de remédiation concluants pour des entreprises de dispositifs médicaux de tailles variées.
    Project Management Planning Regulatory Strategy
  • i-SEEDD
    Independent Consultant in Medical Affairs and Clinical Trials
    SECTEUR MÉDICAL
    janvier 2019 - Aujourd'hui (7 ans et 5 mois)
    Dubai, Émirats arabes unis
    Punctual or long-term support to small/mid-size organizations in increasing medical knowledge & its use + developing clinical trials/local initiatives by:
    - Medical congress attendance, Medical watch on specific topics and report
    - Support in organizing Scientific Advisory Board
    - Medical writing
    - Training & education on scientific topics including HEOR
    - Assessment of clinical sites
    - Review of Clinical Evaluation Reports (CERs) for medical devices
    - Support in strategy and conduct of PMCF (Post-Market Clinical Follow-up) for medical devices
    Medical Writing Clinical Strategy Medical Information

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Formations

  • Health Economics Basics,
    BUSINESS SCHOOL
    2014
    Health Economics Basics,
  • PharmD
    School of Pharmacy, Châtenay-Malabry, Paris XI.
    2003

Compétences

Catégories