Charlélie VENAULT

En résumé

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

• Master Génie Physiologique Et Informatique

  Poitiers 2009 - 2012

Réseau

• Amélie RICROS

• Aymeric MOUCHAIN

• Charlène PIAT

• Emilien SAVÉAN

• Hervé DALUZEAU

• Matthieu BURIN DES ROZIERS

• Patrick GIRARD

• Pierre-Marie MARCHAND

• Quentin GOURBEAULT