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Experiences

Current Experience

  • Pharmacovigilance Officer Benelux

    Anderlecht, Belgium
    Since June 2018

    i'm responsible for Pharmacovigilance for ucb in the belgium, netherlands and luxembourg. this entails:

    • local literature screening
    • local regulatory intelligence
    • management of sdea
    • pv qa
    • pv Training
    • regulatory submission
    • audit(ing)

    I'm responsible for pharmacovigilance for UCB in the Belgium, Netherlands and Luxembourg. This entails:

    • local literature screening
    • local regulatory intelligence
    • management of SDEA
    • PV QA
    • PV training
    • regulatory submission
    • audit(ing)

  • Canine behavioral therapy


    Since January 2012

    k's pack canine behavioral therapy

    you are a women with a nervous and/or excited dog? i can help you to understand your dog better and give you knowledge and skills to have a positive control over your dog.

    K's Pack Canine Behavioral Therapy

    You are a women with a nervous and/or excited dog? I can help you to understand your dog better and give you knowledge and skills to have a positive control over your dog.

Past Experience

  • Pharmacovigilance Officer Kortenberg, Belgium

    February 2018 --- May 2018

    i was responsible for:

    • setting up qa-system
    • Project Management
    • local literature screening
    • local regulatory intelligence screening
    • pv Training
    • mailbox management
    • audits

  • Drug Safety Scientist Lasne, Belgium

    August 2009 --- September 2013

    i worked for ucb, gsk and other Pharmaceutical companies as a Drug Safety Consultant:

    • writing of psurs and dsurs, update rmps for products like cervarix and rotarix (over 2000 cases per report)
    • working with Pharmacovigilance Databases like empirica trace and argus
    • writing of responses to authorities
    • update company SOP to comply with changes in eu laws regarding Pharmacovigilance
    • literature review with regard to Drug Safety using sciencedirect
    • knowledge and working experience with who drug dictionnary and MedDRA
    • review of ae/sae report database to detect inconsistencies or discrepancies at entry from Clinical trials, spontaneous sources or licensee partners, for serious and non-serious reports.
    • approve and comment reported ae/sae cases
    • reporting of ae via eudravigilance
    • screening job applicants for keyrus biopharma pv department
    • contact with new pv clients
    • search outstanding information regarding disease states, concomitant drugs, or suspect drugs.
    • Training fo junior Drug Safety scientists

  • Global Manufacturing Compliance Assistant

    March 2009 --- July 2009
    i was responsible for follow-up on the regulatory part of changes in production lines; i contacted the local departments.

  • Administrative Assistant

    January 2009 --- February 2009
    my responsibilities included answering the phone, forwarding emails and creating an archieve for no-longer-used files.

  • Veterinarian

    January 2008 --- December 2008
    i did replacments; i took over small animal vet practices during holiday, sick or maternity leave of the Owner vet.

  • PhD student

    July 2002 --- September 2002
    new products were tested for their effect on chitin synthesis inhibition in a pest insect, spodoptera frugiperda through a radioisotope (prof. dr. ir. guy smagghe)

  • Intern

    September 2001 --- February 2002
    insect biocontrol Lab (maryland, usa): work with insect Stem cell cultures

Personality

Self Assessment :
Attention to detailCollaborationCompetitivenessCreative thinkingCritical thinkingCommunicativeEfficiencyIndependenceInterest in knowledgeOrganizationProactivityProblem solvingResult OrientedSelf-disciplineStrategic thinkingAdaptability

Knowledge

LinkedIn Assessment :
Dog BehaviorDog TrainingDog WalkingPetsVeterinary MedicineAnimal WelfareAnimal BehaviorDogsSOPAnimal NutritionVeterinaryAnimal HusbandryAnimal WorkPersonal DevelopmentPharmaceutical IndustryCoachingLife SciencesContent MarketingLeadershipPublic RelationsPublic SpeakingBrand ManagementCommunicationB2C MarketingSalesClinical trialsEntrepreneurshipLife SkillsPharmacovigilanceStandard Operating Procedure (SOP)

Skills and Expertise

Self Assessment :
Create SOPs Interact with physicians Search literature on clinical trials Analytical skills Write papersAdverse event reportingAssess adverse reactionsComplete case report form (CRF)Conduct literature searchesData entryOral presentationPlan work to meet objectives and deadlinesPrepare responses to health authority queriesProvide trainingReport serious adverse events (SAE)Statistical analysisWrite documentsWrite final reports

Education

  • Master in Veterinary Sciences from Ghent University in 2007
  • Master’s Degree in Biology - molecular from Vrije Universiteit Brussel in 2001

Training and Certification

  • Career Guidance by Core Talents in 2017 Training
  • Writing clinical protocol BioWin in 2010 Training
  • Body Language for Leaders in 0000 Certification
  • Influencer Interview: Oprah Winfrey in 0000 Certification
  • Sallie Krawcheck on Risk-Taking in 0000 Certification
  • Shane Snow on Storytelling in 0000 Certification
  • Top 5 Speed Reading Tips in 0000 Certification

Languages

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

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Freelance Science Writer Drug Safety Officer Medical Writer Pharmacovigilance Officer Scientific Writer Senior Medical Writer Veterinarian
  • Locations I am interested in:
    Belgium London, United Kingdom Paris, France
  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    32 Hours per week :    100% Free Per Month(in coming months)
  • International:
    Yes

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Kampenhout, Belgium

Others

Driving License
  • Yes

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