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Summary

PhD scientist with 10 year experience in clinical science (late development, marketing authorisation applications), pharmacovigilance, clinical safety, and clinical affairs (company core data sheets, labelling), in both pharmaceuticals and medical devices.

Experiences

Current Experience

  • Senior Manager Clinical Affairs Diegem, Machelen, Belgium
    Since November 2014

    • Risk Master Lists (RML, ~ Company Core Safety Information ‐ CCSI): Introduction of CCSI concept, leading in change project: stakeholder management, change plan development/ implementation/ evaluation
    • Instructions for Use (IFU, ~ Summary of Product Characteristics - SPC) and Patient Guide (~Patient Information Leaflet - PIL): contra‐indication, warning, precaution & anticipated adverse event sections - IFU creation, change orders, regulatory authority & notified body interactions
    • Clinical Evaluation Plans and Reports (CEP/CER): adverse event and complaint data IFU impact assessment (MedDEV 2.7.1, ISO14791)
    • Clinical trial protocols, clinical trial reports, informed consent forms, and investigator brochures: anticipated risks and risk analysis sections (ISO14155, ISO14791)
    • Clinical trial signal detection
    • Departmental and cross‐departmental operating procedures & work instructions
    • CRO oversight & management (including vendor selection, contracts and budget)
    • RML database set-up (capital committee funds, vendor selection, budget, business owner contribution to database specification and validation phases)
    • Corrective Action Plans (initiation/evaluation, investigation, resolution planning, and effectiveness check phases)
    • Management Experience:

      • Managed 3 direct reports (locations: San Francisco area)
      • Managed interactions with 10 internal stakeholder functional groups
      • CRO oversight & management (including vendor selection, contracts & budget)
      • Database set-up (including capital committee funds, vendor selection, budget, business owner contribution to database set-up specification and validation phases)
      • Reporting to global director

Past Experience

  • Senior Manager Clinical Research Safety Diegem, Machelen, Belgium
    October 2011 --- November 2014

    • Worldwide regulatory reporting clinical trial serious adverse events and device deficiencies (ISO14155, MEDDEV 2.7.3, FDA, PMDA, Asia‐Pacific countries; Ethical Committees)
    • Clinical trial protocol, informed consent form, and study reports: anticipated risks and risk analysis sections (ISO14155)
    • Clinical trial signal detection
    • Data Safety Monitoring Boards
    • Investigator Sponsored Studies: concept & protocol review
    • Study set‐up
    • Departmental operating procedures & work instructions
    • Corrective Action Plans
    • Management Experience:

      • Managed 7 direct reports (locations: San Francisco area, New Delhi, Brussels)
      • Managed interactions with 10 internal stakeholder functional groups
      • Member of EMEA Clinical Research cross‐functional Senior Management Team
      • Member of Global Clinical Safety Senior Management Team
      • Reporting to global director

  • Manager Clinical Science Late Development/ Pharmacovigilance Turnhout, Belgium
    June 2007 --- October 2011

    Clinical Science (Pharmaceuticals, Late Development):

    • Marketing Authorisation Application of Prucalopride/Resolor®: Approved by Committee for Medicinal Products for Human Use (CHMP)/European Commission (EC) in Oct 2009, and Swiss Medic in Jul 2010
    • Clinical trial reports, summary of clinical safety (SCS), clinical overview (CO), and initial risk management plan (RMP)
    • Answering safety‐related questions CHMP (Day 120/Day 180 assessment reports) and Swiss Medic
    • CHMP oral hearing preparation
    • Supporting external expert safety report preparation
    • Contributed to Prucalopride Paediatric Investigation Plan (PIP)
    • Publications and congress abstracts
    • Medical information requests (frequently asked questions list, escalated questions)

     

    Pharmacovigilance (Pharmaceuticals):

    • Scientific evaluation of product safety profiles
    • Aggregate safety reports (periodic safety update reports (PSURs), ad hoc reports, and safety summaries)
    • Risk management plans (RMPs) and risk tracking documents
    • Research on scientific questions (literature searches, contacts with experts)
    • Responding to internal and external safety queries
    • Routine surveillance, pro‐active signal detection, aggregate case review
    • Lead and organise multidisciplinary safety review teams
    • Safety input on product development plans, study protocols, investigator brochures
    • Liaising with business partners (CRO) and internal departments
    • Providing internal product safety profile and safety procedures training
    • Pharmacovigilance system set‐up and maintenance:
      • Volume 9A detailed description of pharmacovigilance system
      • Standard operating procedures for pharmacovigilance department
      • Operating guidelines for CRO and local affiliate interaction
      • Pharmacovigilance agreements with co‐development and co‐marketing partners
      • Pharmacovigilance inspection readiness

  • Scientist Wilrijk, Antwerp, Belgium
    October 2002 --- June 2007

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAssertivenessAttention to detailCollaborationCommunicativeCreative thinkingCritical thinkingDiligenceEfficiencyFlexibilityIndependenceInterest in knowledgeOptimismOrganizationProblem solvingResiliencyResponsibilityResult OrientedSelf-disciplineStrategic thinkingTrust

Knowledge

Self Assessment :
21 CFR Part 11Actions and modes of action of drugs in the human speciesActions and modes of action of human physiologyAdverse Events (AE)Biological Drug DevelopmentBiomedical SciencesBiopharmaceuticalsBudget ManagementBudget NegotiationBudgetingBudgetsCAPACardiovascular diseasesCE CertificationChange ControlChange ManagementClinical DevelopmentClinical researchClinical Study DesignClinical study reportsClinical trialsCompliance with regulationsCommunication SkillsComplianceContinuous ImprovementCROCross-functional team leadershipData AnalysisDatabasesDNADNA extractionDNA sequencingDrug DevelopmentDrug development processDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentEnglishFDAGastroenterologyGenetic polymorphismGeneticsGood Clinical Practice (GCP)ICH guidelinesInformed Consent DocumentsISOISO 13485ISO 14971Knowledge of the drug development processLeadershipLife SciencesLifesciencesmanagementMarketing Authorisation Application (MAA)Medical Device R&DMedical DevicesMedical writingMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMolecular geneticsOutlookOutsourcingpeople managementPharmaceutical DevelopmentPharmaceutical ResearchPharmaceuticalsPharmaceuticsPharmacogeneticsPharmacogenomics (study of genetic variation)PharmacovigilancePhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Position PaperPresentation SkillsPresentationsPrinciples and ethics of clinical researchProblem SolvingRegulatory RequirementsReport WritingRisk ManagementSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Safety reportingSafety trialsscienceScientific WritingSerious Adverse Event (SAE)Six SigmaSNOMEDStandard Operating Procedure (SOP)Start-upsTeam BuildingTeam LeadershipTeam ManagementTime Management

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Create SOPs Guide students Interpret data Report data Search literature on clinical trials Write papersAdverse event reportingApprove consent documentsApprove Label Master SheetApprove patient informationAssess adverse reactionsAssess subject safetyAttend seminars, courses and meetings within and outside the companyCoachCoach staffcollaborate in research projects at universitiesCollaborate with project teamConduct studiesCreate clinical documentsDesign database Develop ICH/GCP compliant processesFollow-up of external auditsFollow-up of internal auditsGastrointestinal diseasesGuide studentsImplement Key Performance Indicators (KPI's)Interpret dataInterpret scientific dataLate-stage regulatory filing (MAA, BLA)Maintain Quality Management System (QMS)Maintain strong relationshipsManage budgetsManage complexityManage multiple projectsManage Quality Management System (QMS) documentationManage vendor budgetsmanaging a small teamManuscript preparation and reviewManuscript reviewMarket approvalMonitor Key Performance Indicators (KPI's)Oral presentationOrganise meetingsPeople managementProvide benefit risk assessmentPublish scientific projectsRead medical literatureRead medical literature to maintain current awareness and knowledgeReport deaths to regulatory authoritiesReport Key Performance Indicators (KPI's)Report non-compliance incidentsReport serious adverse events (SAE)Report study conclusionsResolves queriesRespond to audit findingsReview clinical study reportsReview dataReview data interpretationReview protocolsReview reportsReview study protocolsReview the interpretation of dataReview vendor metricsSelect contractors Serious Adverse Event (SAE) ReconciliationSupervise PhD studentsWork collaboratively with the other members of the clinical research team Work cross-functionallyWrite clinical evaluation reportsWrite documentsWrite final reportsWrite papersWriting regulatory documentsWritten presentation

Education

  • PhD in Biomedical Sciences from University of Antwerp in 2007
  • Master in Biomedical Sciences from University of Antwerp in 2002
  • Bachelor in Biomedical Sciences from University of Antwerp in 2000

Training and Certification

  • ISO13485 lead auditor certified in 2016 Certification
  • CAPA certified approver in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Elementary Proficiency
German
Elementary Proficiency
English
Full Proficiency

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Clinical Director Clinical Director Europe Clinical Research Consultant Senior Consultant Team Leader
  • Positions I am NOT interested in:
    Manager
  • Locations I am interested in:
    Antwerp, Belgium Flemish Brabant, Belgium
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Antwerp, Belgium

Others

Driving License
  • Yes