Menu

Yusouf BAH

Bagneux

En résumé

I am a lead safety scientist with double competence in pharrmacovigilance and classical data Management activities in Clinical trials. Experienced in case processing, CRO and pharmacovigilance project management, and safety database validation. Eudravigilance certified, Argus, Arisg database, safety easy, ES1 safety manager.

Mes compétences :
Eudravigilance certified for ICSR declaration
Pharmacovigilance and clinical Data management
FDA inspections management
Database Validation
PL/SQL Programation

Entreprises

  • DBV Technologies - Pharmacovigilance and Drug Safety Manager

    Bagneux 2015 - maintenant

  • UBC: An Express Scripts Company, Geneva, Switzerland - Safety Scientist, Pharmacovigilance

    2013 - 2015 Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required.
    Maintain a listing of all administrative changes and updates.
    Ensure all processes as described operational.
    Alert Project Management when activities fall outside SOW.
    Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment.
    Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings.
    Assist in the reconciliation of clinical and safety databases.
    Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports.
    Perform literature review for identification of case reports and other relevant safety information.
    Liaise with both internal and external vendors (clients, patients and HCPs).
    Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution.
    Monitor compliance metrics and ensure appropriate documentation when deficient.
    Assist in evaluation and validation of systems to support safety.
    Other duties as assigned by management.

  • Orphan Europe - PHARMACOVIGILANCE ASSOCIATE

    2008 - 2013 Case processing (serious and non-serious adverse events/reactions in clinical trial, spontaneous and solicited cases) in secured database system.
    Coding of adverse events/reactions, and medical history.
    Writing case narratives
    Quality control of data and report.
    Transfer data electronically in compliance with ICH E2B and expedition to Eudravigilance database and partners
    Extraction of line listings, using validated SQL programme for regulatory safety reports.
    Elaboration of summary tabulation including post DLP cases.
    Preparation of Corrective Actions Preventive Actions (CAPA).
    Coordinator of database acquisition, preparation data migration plan, data mapping tool, and validation of migrated data

  • Umanis - Data Manager

    Levallois-Perret 2008 - 2008 Clinical operations and data management activities .

Formations

Annuaire des membres :