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Summary

Work experience for 18 years in pharmaceutical industry in positions both at affiliate and regional level. Experience with clinical trial data management, clinical trial study management systems (randomization), drug safety & medical information. Experienced (8 years) lab technician in different research labs (mutagenicity, cytogenetics, histology, ecology). Several years of people management experience (small groups of 4 people). Very system, IT minded. Always striving in getting the best out of IT systems. Dynamic, pragmatic, very customer focused. Person with integrity. Rather a “doer” than a “thinker”.

Experiences

Past Experience

  • Business Unit Manager Pharma Ternat, Belgium
    August 2016 --- November 2016

    • Define campains for quick wins with regards to turnover within Pharma BU
    • Find oppportunities with existing products/solutions
    • Marketing activities for the promotion of pharma products

  • Medical Information & Drug Safety Team Leader
    June 2011 --- February 2016
    Leading the team of Medical Information & Dug Safety Associates and Assistants (4 people). Performance management of team members. Set team objectives together with Medical Director. Ensure replies (phone, email, CRM) to medical questions from customers (HCPs, patients) in Luxembourg and Belgium. Support in medico-legal review of promotional materials within Belgium and Luxembourg. Case management of spontaneous & trial adverse events for Belgium and Luxembourg. Link with the responsible person for complaints and counterfeiting cases. Ensure labeling communication (SPC/PIL) towards internal (marketing) stakeholder and external ones (Pharma.be, AFMPS, etc..).

  • Medical Information & Drug Safety Associate
    February 2004 --- June 2011
    Ensure replies (phone, email, CRM) to medical questions from customers (HCPs, patients) in Luxembourg and Belgium. Support in medico-legal review of promotional materials within Belgium and Luxembourg. Case management of spontaneous & trial adverse events for Belgium and Luxembourg. Link with the responsible person for complaints and counterfeiting cases. Ensure labeling communication (SPC/PIL) towards internal (marketing) stakeholder and external ones (Pharma.be, AFMPS, etc..).

  • European CT-SMS Team Leader/ European Help-desk Coordinator
    February 2001 --- January 2004
    Recruit, train and manage CT-SMS team (4 people). Work with Corporate CT-SMS team on definition and documentation of business procedures, training and support procedures. Ensure proper training of CT-SMS users in Europe. Participate at and ensure Europe business representation in change control board. Marketing of CT-SMS to European affiliates. Budget and Resource planning for CT-SMS in Europe. Define and manage support structure in Europe. Manage relations with external service providers. Effective communication with all stakeholders. .

  • Clinical Trial Study Management System Project Assistant
    January 2000 --- February 2001
    Assist in training and coaching CT-SMS helpdesk employees. Ensure & Verify CT-SMS user satisfaction. Maintain system support tools. Ensure monthly metrics are available. Enable implementation of Corporate CT-SMS studies in Europe. Make sure CT-SMS software is installed at European affiliate user’s PC before start of patient enrolment. Follow up on installation of new software releases. Ensure proper training for European Lilly CT-SMS users and European site IVR users.

  • Clinical Investigation Assistant
    August 1997 --- December 1999
    Data Management of registration trials with Electronic Data Capture system. Assisting in on-site Source Data Verification.

  • First technician, special projects
    January 1989 --- January 1997
    Free University of Brussels, lab for cytogenetics. Worked on European Research projects. Experience with several mutagenicity tests, cytometry. In situ hybridization, histological- and immunostaining. Free University of Brussels, Lab ecology, HPLC determination of chlorophyll in samples from the Schelde in order to study the phytoplankton summer blooms.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailAuthenticityCollaborationCommunicativeDiligenceOptimismEfficiencyFlexibilityInterest in knowledgeTrustService orientedResult Oriented

Knowledge

Self Assessment :
Diabetes Labtechnician21 CFR Part 11Adverse Events (AE)CAPACell biologyChange ControlChange ManagementClinical researchClinical Trial Management System (CTMS)CoachingComplianceDrug Safety and PharmacovigilanceDrug regulatory authoritiesDue DiligenceeCTDElectronic Data Capture (EDC) ElectrophoresisEthics submission and approval processGeneticsGXPHPLCIVRSMedical affairsMicrosoft ExcelMicrosoft PowerpointMicrosoft OfficeMicrosoft WordMolecular & Cellular BiologyOutsourcingpeople managementPharmaceutical IndustryPhase IIIPhase IVPresentation SkillsPrinciples and ethics of clinical researchPharmacovigilanceMultilingualOutlookProblem SolvingRegulatory affairsSafety reportingSAPSearch literature on clinical trialsSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Team Leadership
LinkedIn Assessment :
Clinical trialsPharmaceutical IndustryRegulatory affairsProtocolMedical DevicesDrug SafetyPharmacovigilanceoncologyClinical researchCTMSBiotechnology

Education

  • Bachelor in Science in Pharmaceutical and Biological Laboratory Techniques from Erasmushogeschool Brussel in 1989

Languages

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

Work Preferences

  • Positions I am interested in:
    Drug Safety Officer Medical Affairs Associate Pharmacovigilance Officer QA Officer Regulatory Affairs Associate
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Sint-Katherina-Lombeek, Ternat, Belgium

Others

Driving License
  • No