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Experiences

Current Experience

  • Freelance consultant San Diego, CA, United States
    Since April 2017

  • Senior Associate Pharmacovigilance Quality Assurance San Diego, CA, United States
    Since August 2016

    Quality Assurance for Pharmacovigilance activities

    PVQA Auditor

Past Experience

  • Qualified Person - QA Manager Gosselies, Charleroi, Belgium
    March 2012 --- July 2016

    Qualified Person

    QA Manager

    Regulatory Affairs support

     

    Cell therapy products in clinical trials

  • Industrial Pharmacist Brussels, Belgium
    October 2010 --- March 2012

    Pharmacovigilance

    Regulatory Affairs

    Back-up QP

    QA

    Production support

     

    Marketed chemical drugs

  • Trainee
    February 2010 --- June 2010
    3 months internship at TetraQ (Brisbane, Australia) (part of the postgraduate master)

Knowledge

Self Assessment :
Quality SystemsQuality Assurance (QA)PharmacovigilanceClinical trialsMarketing Authorisation Application (MAA) Cell biologyRegulatory affairsQuality Management System (QMS)Drug Safety and PharmacovigilanceBiotechnologyPharmaceutical SciencesGood Manufacturing Practice (GMP)Good Distribution Practice (GDP)ISO 9001Quality ManagementQuality Auditing
LinkedIn Assessment :
Regulatory affairsPharmacovigilanceQuality Assurance (QA)GMPBiotechnologySOPValidationChange ControlGXPPharmaceutical IndustryCAPARegulatory submissionsClinical trialsQuality SystemsBiopharmaceuticalsAseptic ProcessingPharmaceuticsGCPDrug Development

Education

  • Complementary master's degree in Total Quality Management from UMONS in 2015
  • Complementary master's degree in Pharmaceutical industry from Université catholique de Louvain in 2010
  • Master's degree in Pharmaceutical sciences from Université catholique de Louvain in 2009
  • Bachelor's degree in Pharmaceutical sciences from Facultés universitaires 'Notre-Dame de la Paix' in 2007

Training and Certification

  • QP - QPPV Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Dutch
Elementary Proficiency
French
Native

Area / Region

San Diego, CA, United States

Others

Driving License
  • Yes