Director, Safety Lead Neuroscience New MedicinesBelgium
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.
Director, Safety Physician/Safety Lead Established ProductsApril 2013 --- March 2015
coordination of cross-functional Drug Safety deliverables, signal and benefit-risk assessments.
Head of Medical and Scientific Expertise EU at Drug SafetyMay 2012 --- March 2013
Safety Director & Head of Internal Medicine EU, Global Clinical Safety and PharmacovigilanceMarch 2011 --- April 2012
Associate Director Global Drug Safety and PharmacovigilanceJanuary 2008 --- February 2011
CRA/ Clinical Team Leader Moscow, RussiaAugust 2000 --- May 2002
Post-Graduate Specialization and ResearchAugust 1997 --- December 2001
Strategic thinkingCritical thinkingInnovative thinkingOrganizationCoordinationAssertivenessCollaborationAdaptabilityAuthenticity
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
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