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  • Solid history in delivering medical support for pharmacovigilance and clinical trial protocol synopses.
  • Knowledgeable in the areas of clinical research and regulatory affairs in Europe related to clinical studies and healthcare management.
  • Adept at conducting clinical trials/studies for evaluating medical, surgical, or behavioural intervention in compliance with Good Clinical Practice (GCP) and regulatory requirements.
  • Proven expertise in clinical research, consultation services, contract negotiation, business development, and record management systems.
  • Multi-lingual with operational command over English, Hungarian, and Swedish.

Experiences

Current Experience

  • Medical reviewer

    Budapest, Hungary
    Since January 2018
    Clinical research

    Deliver medical and scientific input to clinical research programmes, lead medical safety assessment and related activities for assigned molecules. Serve as point of contact for all medical related queries and execute medical review of individual safety cases. Provide medical expertise and judgement throughout case-handling process with evaluation of individual cases, including completing CCC (company clinical comment) based on the Product Safety Information and Core Data Sheet. Determine medically important events and resolve requests of AE coding in MedDRA. Communicate with global safety physician and assist in defining content of PSUR comment.

Past Experience

  • Medical consultant Beijing, China

    June 2015 --- January 2018
    Business Development

  • Clinical Research Associate (CRA) Stockholm, Sweden

    July 2013 --- February 2015
    Phase III

  • Clinical Research Associate (CRA) Sweden

    August 2009 --- November 2012
    Adverse Events

  • GP Trollhättan, Sweden

    January 2007 --- October 2008
    Diabetes

  • GP Budapest, Hungary

    July 2004 --- December 2006
    Diabetes

Personality

Self Assessment :
Attention to detailCuriosityInterest in knowledgeResponsibilitySelf-disciplineStrategic thinking

Knowledge

Self Assessment :
DiabetesAseptic ProcessingAseptic TechniquesBacteriologyCancer ResearchCardiovascular diseasesClinical monitoringClinical researchClinical Trial Management System (CTMS)Clinical trialsCROData entryDNADrug development processDrug Safety and PharmacovigilanceElectronic Data Capture (EDC) EnglishFamily practiceGeneral MedicineGood Clinical Practice (GCP)Healthcare industryHuman AnatomyInformed Consent ProcessInternal medicineMarketingMonitoring Study ProgressMultilingualOncology Clinical ResearchPharmaceutical IndustryPharmacovigilancePhase IIPhase IIIPhase IVPrinciples and ethics of clinical researchProtocolRandomization and blindingRandomization SystemsSafety reportingSerious Adverse Event (SAE)Standard Operating Procedure (SOP)SterilizationStudy protocolsUnderstanding of regulatory guidelines

Skills and Expertise

Self Assessment :
Assure medical quality Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trials Use a confocal microscopyAct as the main line of communication between the sponsor and the investigatorAdverse event reportingAdvise on medical perspectivesApprove patient informationAseptic techniquesAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyCollaborate with principal investigatorCommunicate with investigatorConduct close-out visitsConduct literature searchesConduct site initiationConduct studiesData verificationEnsure good clinical practice (GCP)Informed consent processInteract with nursesInteract with pharmacistsInteract with physiciansProvide trainingSite management

Education

  • MD in Medicine from Semmelweis University in 2001
  • Associate in Business Administration (MBA) from Center for Business Studies in 1997

Training and Certification

  • GCP in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Hungarian
Native
English
Professional Proficiency
Swedish
Professional Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Södertälje, Sweden

Others

Driving License
  • Yes

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