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Experiences

Current Experience

  • Therapeutic area lead CSPV, Director

    Frankfurt, Germany
    Since March 2015

Past Experience

  • Associate Director, Medical writing Geneva, Switzerland

    January 2013 --- March 2015

  • Pharmacovigilance Project Leader Suresnes, France

    May 2009 --- January 2013

  • Senior Medical Advisor Sèvres, France

    May 2007 --- May 2009

  • Pharmacovigilance Officer Suresnes, France

    September 2006 --- May 2007

  • Pharmacovigilance officer Paris, France

    April 2006 --- September 2006

  • Pharmacovigilance officer Paris, France

    September 2004 --- April 2006

  • General Practitioner Bobigny, France

    July 1988 --- February 2006

  • Clinical Research Physician Nanterre, France

    June 2001 --- September 2004

  • Clinical Study Monitor Bobigny, France

    January 1989 --- June 1993

Personality

Self Assessment :
AdaptabilityAnalytical thinkingCollaborationInnovative thinkingPerspectiveTrust

Knowledge

Self Assessment :
PharmacovigilancePhases of clinical development (phase I to IV)PowerPoint DiabetesCancerCardiovascular diseasesClinical Data ManagementClinical researchComplianceCRODrug DevelopmentDrug Safety and PharmacovigilanceFDAGeneral practiceGood Clinical Practice (GCP)ICH guidelinesInformed Consent ProcessKnowledge of the drug development processMedical writingMicrosoft ExcelMicrosoft PowerpointMicrosoft WordNephrologyNew Drug Application (NDA)Problem SolvingReport WritingRisk AssessmentRisk ManagementSafety reportingSafety trialsSerious Adverse Event (SAE)

Skills and Expertise

Self Assessment :
Analytical skills Interact with physicians Interpret dataAdverse event reportingApprove consent documentsAssess adverse reactionsAssist with proceduresAttend investigator meetingCommunicate with investigatorData codingInteract with regulatory stakeholdersInterpret scientific dataLead teamsManuscript reviewManuscript preparation and reviewMonitor dataPrepare regulatory documentsPrepare responses to health authority queriesPresent data at congressProvide benefit risk assessmentProvide trainingReport serious adverse events (SAE)Review clinical study reportsReview medical reportsReview protocolsSerious Adverse Event (SAE) ReconciliationValidate dataVerify dataWork collaboratively with the other members of the clinical research team Work with coordination and data management teamsWrite documentsWrite medical reports

Education

  • Master in Statistics in Clinical Trials and medicine from Universtite de PARIS XI in 1990
  • MD in Medicine from Universtite de PARIS XIII in 1988

Languages

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

Area / Region

Frankfurt, Germany

Others

Driving License
  • Yes

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