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Summary

OBJECTIVE Personal assistant or any other function requiring administrative and organisation skills in a structured context, even international, offering a continuous learning perspective.

PROFESSIONAL EXPERTISE AND SKILLS

4 years - Administrative Assistant

9 years - Drug Safety in the pharmaceutical industry

6,5 years - Coordination of clinical trials ,in hospital

Administrative skills:

• Administrative support: agenda, mailbox, telephone, meetings’minutes, mails, PPT presentations

• Trilingual trainings & translations (En, Fr, Nl)

• Update/Writing of official documents • Active use of various medical databases 

 

Accurate, wilful, systematic with an analytical approach 

Proactive, reliable, available, quickly adaptable to new situations

Experiences

Past Experience

  • Drug Safety Officer Diegem
    August 2014 --- November 2014

     

    Replacement contract :

    • Safety cases handling: pharmacovigilance mailbox => pre-submission to Health Authorities

    • Queries and reminders to reporters

     

     

     

     

  • Administrative Assistant - P.K. Halstead Associates, Brussels
    February 2014 --- May 2014
    Company's central mailbox handling, PPT présentations, travel organisation, review of administrative documents in Word, Excel & PPT

  • Administrative Assistant - Legal Department Brussels
    June 2013 --- December 2013

    Administrative assistant to the head of legal department: mailbox,phone contacts and reception of customers

    Support to legal colleagues on tax regularisation in Belgium

    Liase between front office and middle office

  • Safety Analyst Waterloo
    March 2007 --- September 2012

     

    Safety Analyst outsourced as consultant at GSK Biologicals, UCB Pharma and Besins Healthcare

    Safety cases handling: pharmacovigilance mailbox => pre-submission to Health Authorities (therapeutic areas: immunology, oncology, hematology, CNS, general medicine, vaccines)

    Writing of narratives, company comments, queries

    Events coding with MedDRA dictionnary

    Listedness and expectedness on basis of reference documents (Company Core Datasheets, Investigator Brochure, Patient Leaflet

    Clinical studies reconciliations

  • Drug Safety Officer Brussels
    February 2002 --- December 2006

    Safety cases handling: pharmacovigilance mailbox => pre-submission to Health Authorities (therapeutic areas: immunology, vaccines, general medicine, oncology, respiratory and cardiac diseases.

    Trilingual courses on safety procedures/principles

    Implementation of  the European CT Directive, valid from 01 May 2004

    Administrative support: translations, updating/writing of official  documents

     

     

     

     

     

     

     

     

     

  • Clinical Studies Coordinator Brussels
    January 1998 --- August 2001

    Cooordination of studies: sponsored trials, "compassionate use" programs, investigator initiated studies.

    Handling of medical data presented at congresses/for publications

Personality

BrightOwl Assessment :
Attention to detailDependabilityInterest in knowledgeCuriosityPerspectiveEmotional reactivitySelf-discipline
Self Assessment :
Emotional reactivityInterest in knowledgeCuriositySociabilityIndependence

Knowledge

BrightOwl Assessment :
Life SciencesMultilingualoncologyHematologyImmunology
Self Assessment :
Allergy and immunologyCancerClinical trialsCROData entryDrug Safety and PharmacovigilancedutchEnglishFrenchGCPGood Clinical Practice (GCP)Gynecologic oncologyHealthcare industryHematologyHospitalsInfectious diseasesoncology
LinkedIn Assessment :
PharmacovigilanceExcelWordEnglishPowerPointGCPOutlookMicrosoft OfficeClinical researchMedDRAPharmaceuticalsoncologyHospitalsCROLife SciencesMicrosoft WordPharmaceutical IndustrySecretarial SkillsAdministrative Assistants

Skills and Expertise

BrightOwl Assessment :
Analytical skills organizeAnswer, transfer and handle incoming calls as needed.Capture data on source documentsCommunicative skills
Self Assessment :
Capture data on source documentsData verificationEnsure data consistencyEnsure data integrity

Education

  • Master's degree (cum laude) in Biomedical Sciences (Microbiology, infectious pathology, immunology) from UCL, Faculty of Medicine in 1989
  • Bachelor of Science (B.S.) in Zoological Sciences from UCL, Faculty of Sciences in 1987
  • Baccalauréat D in Maths & Biology from French International School, Washington DC, USA in 1983
  • in from Le Mans, France: High school. Orientation: Maths, Physics & Biology in 1982

Training and Certification

  • New Pharmacovigilance Legislation – Directive 1235/2010 & 2010/84 in 2012 Training
  • Introduction to Medical Writing in 2012 Training
  • Good Clinical Practice for Monitors in 1996 Training
  • Economy, accounting, marketing and office management (Melius plus, Brussels, Belgium) in 2013 Certification

Languages

BrightOwl Assessment:
German
Elementary Proficiency
Self Assessment:

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    No

Area / Region

Brussels

Others

Driving License
  • Yes