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Fatima BOUCHA

ANTONY

En résumé

Mes compétences :
Vaccins
Essais cliniques
Saisie sur base de données
Immunotherapie
Etudes post marketing
Pharmacovigilance
Recherches des cas literature
Résistance aux antibiotiques
Autonomie
Adaptabilité
Réactivité
Travail en équipe
GVP
Industrie pharmaceutique
Allergies
Rigueur
Affaires réglementaires
PSUR
MedDRA
Veterinary analysis
Public relation skills
Triage
Quality Control
Pharmacovigilance training
Pathology
Microsoft Word
Microsoft PowerPoint
Microsoft Excel
Languages Skills
ICSR Processing
Data Entry
Clinical Trials
Antibiotics
Listes de codes
SAS
Réconciliation/deviation
SQL
WhoDD
clintrial

Entreprises

  • Stallergenes - Data entry officer

    ANTONY 2014 - maintenant In charge of the pharmacovigilance activities of ORALAIR launched in USA, especially data entry

    * Handle pharmacovigilance cases from post marketing, literature, clinical trials,
    ANSM and pregnancy cases.
    * Management of pharmacovigilance cases of specific immunotherapy products (allergens extracts: ORALAIR, NPP (named patient product) and several other products ) ;
    * Receipt, triage, processing and distribution of pharmacovigilance cases received for marketed and investigational products in accordance with EU pharmacovigilance regulation:
    * Duplicate check and data base query
    * Causality assessment ( French and WHO)
    * MedDRA coding ;
    * English narrative / company comments writing ;
    * literature searching skills ;
    * Quality check of CIOMs before distribution to subsidiaries ;
    * Compilation of data and cases documentation
    * Follow up requests and closure cases ;
    * Classification and archiving data of different products in accordance with procedures ;
    * Keep update submission calendars ;
    * Review pharmacovigilance data format of the database in a usable format for the
    periodic safety reports writing
    * Implementation of new functionalities for pharmacovigilance database

  • For Drug Consulting - Drug safety officer - training

    2013 - 2013 - Processed all cases in the local pharmacovigilance database (Base Safety Easy, E2B fields)
    - Learnt pharmacovigilance’s new regulations, July 2012
    - Processed 30 drug safety cases (post marketing & clinical trial) in 3 different therapeutic areas
    - Reviewed, ranked and verified case-related information: event terms; validity, seriousness, special scenarios; accuracy; timelines and consistency. Processed cases based on these assessments
    - Wrote fluently case narrative in English, 2 periodic reports PSURs
    - MedDRA coding, French imputability and WHO Assessment

  • Veterinary doctor - Veterinary doctor

    2012 - 2013 Pathology and medical semiology ,

  • Blida university - Thesis

    2011 - 2012 Thesis about bacterial resistance to antibiotics
    food quality control in the laboratory veterinary analysis

Formations

Pas de formation renseignée

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