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Christophe ADAMY

Suresnes

En résumé

- Clinical & postmarketing Development.
- Basic & Clinical Research.
- Pharmacovigilance.
- Senior Medical Writer (Head of dept.).
- Line/Team management.
- Project management / coordination.
- Selection, training and management of subcontractors.
- Cardiovascular, Fibrosis and Oncology.
- Pharmaceutical Industry.

Mes compétences :
Industrie pharmaceutique
Recherche clinique
Gestion de projet
Recherche et Développement
Pharmacovigilance
Cardiovasculaire
Management
Recherche médicale clinique

Entreprises

  • Servier - Head of Oncology Medical Review Department

    Suresnes 2019 - maintenant
  • Servier - Medical Validation & Safety Activities Manager

    Suresnes 2014 - 2019
  • Servier - Medical Data Officer

    Suresnes 2013 - 2014
  • Sanofi - Pharmacovigilance Scientist /Drug Safety Associate

    Paris 2012 - 2013 In the Safety Surveillance & Risk Management Dept. :

    • Signal detection activities.
    • Safety and benefit-risk evaluations for assigned products.
    • Management of potential safety issues for assigned products.
    • Evaluation of the respective databases for safety signals and, in collaboration
    with Safety Officers to formulate responses to regulatory inquiries on product safety issues.
    • Review of literature and review and summary of large safety data sets presentation of results in draft reports.
    • Development and review of documents such as RMPs, DRMPs, ad-hoc responses
    and PSUR and IB contributions.

    Periodic Safety Reports :

    • Create documents that meet client expectations by conveying a concise and well founded safety message (PSURs, DSURs, PSS).
    • Participate in assigned Safety Analysis Team: Reviewing/analyzing and contextualizing safety data from different data sources for that product or group of products, Sharing available safety information regarding a product or a group of products.
    • Maintain the Safety Tracking Document for products included in the SAT: contextual documentation of all safety information and safety surveillance activities.
  • Sanofi - Senior Medical Writer

    Paris 2008 - 2012 -Production of clinical documents in a timely manner for worldwide registrations.
    - Coordination of all documents production in a project.
    - Ensure the quality, compliance with internal and external standards for all the documents of a project in a functional management way.
    - Provide dedicated scientific authoring expertise to ensure that the clinical opinion is presented accurately and concisely.
    - Liaise with external services and review documentation generated elsewhere, and internal staff.
    - Participation in the mentoring and/or training of junior colleagues, coordinate external contractors and maintain close contact with external department.
    -Located in France with coordination of teams in Germany and the US
  • Umanis Clinical Research - Responsable du département Rédaction Médicale

    Levallois-Perret 2006 - 2007 -Line Manger of 5 MW -
    Design and proposition force for clinical studies,
    -Implementing medico-marketing communication program,
    -Writing support for results presentation,
    -Medical coding (MedDRA & WHOdrug),
    -Clinical study reports and scientific publications writing,
    -Investigator’s Newsletters writing,
    -Management of outsourced and insourced staff,
    -Commercial and financial proposition,
    -Definition of work scope of the department.

    (Johnson&Johnson, Sanofi-aventis, Sanofi-Pasteur, Servier, Menarini, Schering-Plough, Danone, Yoplait, Innéov)
  • INSERM - Post-doctoral Fellow

    PARIS 13 2003 - 2005
  • Charité - Umboldt University - Post-Doctoral fellow - Cardiovascular

    2002 - 2003 Project Leader
    Cardiovascular, angiogenesis and stroke

Formations

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