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Charlélie VENAULT

Suresnes

En résumé

Mes compétences :
BusinessObject
InSight (Liquent)
XEVMPD/IDMP
Register (Aris Global)
RIMS

Entreprises

  • Groupe ProductLife - Consultant for XEVMPD/IDMP and RIMS

    Suresnes 2015 - maintenant IDMP/XEVMPD activities:
    - Responsible of XEVMPD (regulatory surveillance, guidance analysis, submissions via EVWEB and RIMS),
    - Aligning data organization in RIMS to be compliant with xEVMPD requirement,
    - Participation to the pilot phase for collecting and analyzing the data about products representative of the portfolio ; gap analysis versus IDMP requirements,

    RIMS (Register and InSight)/EDMS activities:
    - Support, advices and business process design regarding migration from a RIMS to another one,
    - Validation phase (OQ) of a RIMS,
    - Training documentation design and preparation (user guide, slide set, exercise) supporting the roll out of the RIMS,
    - Data alignment and maintenance in a RIMS for medicinal products and devices,
    - Migration qualification of Documentum database: analysis, testing and quality control of pilot dossiers,

    Publishing activities:
    - Regulatory submission (eCTD, NeeS, Paper) in EU, US, CH with InsightPublisher and update of user guide in accordance,

  • MODIS France - Consultant for RIMS and XEVMPD - Regulatory Affairs

    Puteaux 2012 - 2015 Servier Laboratories – Regulatory Affairs
    − Functional administrator of regulatory database (Register Aris Global)
     Support and advise to users (around 150 users)
     Control of data regulatory consistency of marketing authorisation
     Extension of Register to subsidiaries
     Entry of regulatory events (variations, renewal, MA dossier, etc.)
     Trainer for headquarter and subsidiaries and writing of user guide
     Management of upgrade (exchange with editor and IT team, change control management, validation)
    In charge of EVMPD submissions (EudraVigilance Medicinal Product Dictionary) to EMA with REGISTER® and regulatory surveillance regarding new xEVMPD requirements
    − Responsible of data extractions from Register with BusinessObject: report creation (WRA activities, quality control, PSUR…), and creation of automated report to share information with WRA persons in SharePoint

  • Les Laboratoires Servier - Stagiaire Affaires Pharmaceutiques Mondiales, Division Coordination des Projets

    2012 - 2012 Lieu:
    Département des Affaires Pharmaceutiques Mondiales (Affaires Réglementaires), division de la Coordination des Projets.

    Sujet:
    - implémentation d’un nouvel outil de gestion des AMMs: participation aux workshops de configuration de l’outil avec l’éditeur, migration des données, validation du système et préparation à la mise en production,
    - mise en place d’évolution d’intranets sous SharePoint,
    - extraction de données règlementaires avec Business Object.

  • Les Laboratoires SERVIER - Stagiaire Affaires Pharmaceutiques Mondiales, division Coordination des Projets

    2011 - 2011 Lieu :
    Département des Affaires Pharmaceutiques Mondiales (Affaires Réglementaires), division de la Coordination des Projets.

    Sujet:
    - implémentation d’un nouvel outil de gestion des AMMs: choix de l’outils à partir d’une chek list de fonctionnalités, préparation à la migration des données,
    - mise en place d’un intranet sous SharePoint
    - extraction de données règlementaires avec Business Object.

Formations

Réseau

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