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Summary

"You have to avoid preaching common success as the main goal of life. The most motivating reason to work is in the pleasure you find in it, in the pleasure of the achieved goal and the knowledge of the result's value." A. Einstein

Experiences

Current Experience

  • Head of Pharmacovigilance Excellence & Compliance Wavre, Belgium
    Since December 2017

Past Experience

  • Global Process Owner
    September 2015 --- November 2017

    • Subject Matter Expert (SME). • Build an effective operating model based on good understanding of the current state, defining the target state and establishing a plan to streamline & standardize processes • Benchmark standards: Baseline definition and KPIs management • Ensure user compliance • Prioritize, lead & enable process improvement initiatives, methodology and process by generating new ideas and proposals for implementation. • Global expert on the assigned VCSP procedures. First point of contact for all functions executing the assigned processes • Maintains current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence and industry standards pertaining to the system and improves systems based on this knowledge. • Review Vaccine specific audit information pertaining to the process. Provide expert advice on responses to audit observations. • Represent VCSP at internal and external meetings with pharmacovigilance process focus, including third parties, other pharmaceutical companies and/or regulatory authorities • Accountable for maintaining personal readiness in response to internal audit or regulatory inspection • Capability builder: • Leads networks: Build network with other SMEs, stakeholders and single points of contacts (SPOC) internally (both across GSK Vaccines & Pharma) and externally to share learnings, best practices and support monitoring and improvement initiatives. • Global training owner: deliver process training to VCSP staff, cross-functional stakeholders • Lead process discussions, training and implementation for assigned processes with outsourcing partners

  • Safety scientist
    September 2014 --- September 2015
    Actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks. In this context: : • Coordinate and perform analyses of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure • Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects • Provide input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical study data and lead the safety analyses of the assigned projects. • Contribute to the creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects. • Contribute to the Benefit Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects Pharmocivigilance Literature review process owner (SME)

  • Regional Publications Manager Europe
    February 2013 --- August 2014
    •Facilitates the delivery of regional peer-reviewed publications and integrates the regional planning in regards to stakeholders needs in alignment with global Data Dissemination plans (DDPs), publication scientific and ethical standards (e.g. ICMJE, GPP2), public disclosure requirements, and GSK policies. •Collaborates with clinical/medical affairs, epidemiology, health outcomes; regional investigators and vendors; authors; journal editors and congresses to ensure timely disclosure of data is delivered in an accurate, transparent and balanced manner. •Facilitates and documents discussions on manuscript development and relevant decisions made by the authors and team. •Performs quality control checks of publications prior to submission, including process documentation and archiving. •Trains the regional stakeholders, including investigators at investigator meetings, on the publication process and provides guidance on scientific and ethical publication standards. •Provides regional support for the delivery of global publications.

  • Publications Manager
    September 2011 --- August 2013
    As a HSV/Flu seasonal Publication Manager, I'm responsible for the planning and delivering of scientific publications related to the projects, and this, in collaboration with a multi-disciplinary team of experts. The function of Publication Manager includes key responsibilites with regards to the publication of clinical data, such as the development of publication plan based on data availability and the target product profile. Being a Publication manager is improving my quality of coordinator and scientist on a daily basis.

  • Project Leader
    March 2010 --- September 2011

  • PhD student
    February 2006 --- March 2010
    « Characterization of Dermal Equivalent and Human Skin Equivalent reconstructed in vitro and application to photo-ageing issues » Funded by a First-DEI grant (Région Wallone/StratiCELL S.A)

  • Scientist
    February 2005 --- November 2005
    mice BRSV infection model to test reliability of vaccines and adjuvants

Personality

Self Assessment :
AdaptabilityAssertivenessCollaborationCommunicativeCreative thinkingOrganizationProactivityProblem solvingResiliencySelf-confidenceStrategic thinkingResponsibilityTrust

Knowledge

Self Assessment :
Biochemistry Cell biology Negotiation R&DAdverse Events (AE)BiologyBiological Drug DevelopmentBiopharmaceuticalsBudget NegotiationBusiness ProcessCAPAChange ManagementCommunication SkillsComplianceCompliance with regulationsContinuous ImprovementContract negotiationCROCross-functional team leadershipDrug Safety and PharmacovigilanceDrug safety assessmentDrug regulatory authoritiesDue DiligenceEMAEnglishGood Publication Practice (GPP)GXPInfectious diseasesIt skillsLeadershipmanagementMicrosoft ExcelMicrosoft PowerpointMicrosoft WordMultilingualNegotiationOutsourcingpeople managementPharmaceutical managementPharmaceutical IndustryPresentation SkillsProblem SolvingProcess improvementProcurementProject ManagementQA complianceRisk AssessmentRisk ManagementSafety reportingSerious Adverse Event (SAE)
LinkedIn Assessment :
Project ManagementPublicationsPublication DevelopmentPublication PlanningPublication StrategyCell CultureCell biologyVaccinesVaccinationsClinical trialsBiotechnologyLife SciencesPharmaceutical IndustrymanagementPharmacovigilanceCROChange Management

Skills and Expertise

Self Assessment :
Create SOPsAdjust processes Adverse event reportingCalculate process efficiencyCoachDevelop training materialsDirect co-workers to achieve resultEstablish contractsEstimate subject complianceEthics committee applicationFollow-up of internal auditsGuide staffIdentify risksImplement Key Performance Indicators (KPI's)Implement data reporting systemsImplement ProcessesInteract with computer specialistsInteract with CROsManage budgetsManage complexityManage contractors Manage risksManage vendor budgetsmanaging a small teamNegotiate budget NetworkNegotiationOral presentationOrganise meetingsPeople managementPrepare internal auditsproject managementProvide trainingQuality control processRead medical literatureReport Key Performance Indicators (KPI's)Respond to audit findingsReview quality control activitiesReview vendor metricsSelect contractors Solve problemsSupport due diligence assessmentsTrain StaffWork cross-functionally

Education

  • in from in 2010
  • PhD student in Biology from University of Namur in 2010
  • Master in Biological Sciences from university of namur in 2003

Languages

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

Work Preferences

  • Notice Period:
    6 weeks
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Belgium

Others

Driving License
  • Yes