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Experiences

Current Experience

  • Director, Safety Lead Neuroscience New Medicines

    Belgium
    Since April 2015

    Member of the project governance teams. strategic Leadership in safety and risk managemnet for phase 1-2 pipeline products in CNS ta (epilepsy, parkinson's disease). coordination of the crossfunctional mission team deliverables, benefit-risk team Leadership, matrix team Leader at Patient Safety. key deliverables: safety  Risk Management Strategy, benefit-Risk Assessment, safety measures and outcomes in Clinical Development plan, study protocols, scientific advice with ha, safety differentiation for target product profile.

    Member of the project governance teams. Strategic leadership in safety and risk managemnet for Phase 1-2 pipeline products in CNS TA (Epilepsy, Parkinson's Disease). Coordination of the crossfunctional Mission Team deliverables, benefit-risk team leadership, matrix team leader at Patient Safety. Key deliverables: safety  risk management strategy, benefit-risk assessment, safety measures and outcomes in clinical development plan, study protocols, scientific advice with HA, safety differentiation for target product profile.

Past Experience

  • Director, Safety Physician/Safety Lead Established Products

    April 2013 --- March 2015
    coordination of cross-functional Drug Safety deliverables, signal and benefit-risk assessments.

  • Head of Medical and Scientific Expertise EU at Drug Safety

    May 2012 --- March 2013

  • Safety Director & Head of Internal Medicine EU, Global Clinical Safety and Pharmacovigilance

    March 2011 --- April 2012

  • Associate Director Global Drug Safety and Pharmacovigilance

    January 2008 --- February 2011

  • Clinical Project Leader and Project Manager

    January 2007 --- December 2007
    coordination of a Pharmaceutical product lyfe cycle team in transition of a product from pre-clinical to clinical phases. providing target product profile, Clinical Development plan

  • Clinical Research Physician

    May 2002 --- December 2006
    Clinical Development, CNS, phases iib - iv, medical affairs responsibility

  • CRA/ Clinical Team Leader Moscow, Russia

    August 2000 --- May 2002

  • Post-Graduate Specialization and Research

    August 1997 --- December 2001
    psychiatrist

Personality

Self Assessment :
Strategic thinkingCritical thinkingInnovative thinkingOrganizationCoordinationAssertivenessCollaborationAdaptabilityAuthenticity

Knowledge

Self Assessment :
Clinical researchBusiness DevelopmentClinical DevelopmentDrug development processDrug DevelopmentEarly development stageKnowledge of the drug development processDeveloping Clinical Trial ProtocolsPharmaceutical DevelopmentPhases of clinical development (phase I to IV)Product developmentMarket researchPre-clinical research R&DCompliance with regulationsClinical study reportsInterpret clinical trial resultsTranslational MedicineNew Business DevelopmentDrug Safety and PharmacovigilancePreclinical Safety
LinkedIn Assessment :
PharmacovigilanceClinical DevelopmentClinical researchGCPDrug SafetyMedical affairsCROSOPEpilepsyNeurologyPsychiatrySafety Risk ManagementBusiness Strategy

Education

  • Master of Business Administration (MBA) in Business Administration and Management, General from University of Phoenix in 2014
  • Doctor of Medicine (MD) in from First Moscow State Medical University named after I.M. Sechenov in 1997

Area / Region

Belgium

Others

Driving License
  • Yes

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