Alla Axelbant

Angestellt, Senior Specialist Pharmacovigilance, Otsuka Novel Products GmbH
München, Germany

Fähigkeiten und Kenntnisse

Pharmakovigilanz Dienstleistungen
 Literatur- und Datenbankscreening
Case processing
 Medical Review von CRF mit Prüfung der Daten auf
 Plausibilitätsprüfung von SAEs und SAE Reconcili
CRF Annotation (CDISC-SDTM)
CRF Entwicklung
 Query Management
 Erstellung von Data Validation Plans und Validat
 Verfassen von Narratives und Sender’s Comments
 Erstellung und Pflege von studienspezifischen Ko

Werdegang

Berufserfahrung von Alla Axelbant

  • Current 4 years and 1 month, since May 2022

    Senior Specialist Pharmacovigilance

    Otsuka Novel Products GmbH

  • 3 years and 3 months, Mar 2019 - May 2022

    Drug Safety Specialist

    Otsuka Novel Products GmbH

  • 9 months, Jun 2018 - Feb 2019

    Drug Safety Department (Otsuka Novel Product GmbH) via Cromsource

    Otsuka Novel Products GmbH

  • 1 year, Jan 2017 - Dec 2017

    Drug Safety Department (Grünenthal Germany)

    via CROMSOURCE

    initial triage of the received safety notifications; case processing of individual case safety report including data entry in Connect-database; follow-up ICSRs with the reporter, generate follow up (FU) queries and send FU requests; ICSR reconciliations; preparation for archiving of ICSRs and other safety relevant documents

  • 4 months, Jan 2016 - Apr 2016

    Training period as Drug Safety Officer (Pharmacovigilance)

    Dr. Notghi Academy, Berlin

  • 7 years and 3 months, Oct 2007 - Dec 2014

    Medical Data Reviewer, Clinical Data Coding Specialist

    Aptiv Solutions

    Medical monitoring, meddra medical coding, ClinTrial, evaluation, plausibility, query handling, SAE reconciliation, translate CRF entries, Drug Safety

  • 4 months, Jun 2007 - Sep 2007

    Training period as Medical Data Reviewer

    ClinResearch GmbH

    Medical monitoring, meddra medical coding, ClinTrial, evaluation, plausibility, query handling, SAE reconciliation, translate CRF entries

  • 5 months, Nov 2002 - Mar 2003

    Training periods as Medical Statistician

    Coordination center for clinical studies in the university clinic of Düsseldorf

  • 2 years and 2 months, Sep 1997 - Oct 1999

    doctor for clinical lab diagnostics

    hospital No. 144, St-Petersburg, Russia

Ausbildung von Alla Axelbant

  • 7 months, Oct 2015 - Apr 2016

    Drug Safety Officer

    Dr. Notghi Academy, Berlin

    Certificate in drug safety officer, regulatory guidelines, processing and reporting of SAEs, Literature Screening for safety signals and ICSRs, CRF development, SDTM CDISC.

  • 6 months, Mar 2007 - Aug 2007

    Clinical research - CRA / Clinical Data Manager

    mibeg-Institute Cologne

    Certificate medical coding, GCP, monitoring, terminology, pharmacology, medicament right, data management, project management, Medical English, health economy

  • 1 year, Feb 2002 - Jan 2003

    Medical informatics

    mibeg-Institute Cologne

    Certificate in medical informatics, SAS, SPSS, MS Office

  • 2 months, Sep 1999 - Oct 1999

    Clinical lab diagnostics

    Medical academy, St-Petersburg, Russia

    cytological diagnoses for samples taken via endoscopies and puncture tests

  • 3 months, Oct 1997 - Dec 1997

    Clinical lab diagnostics

    Medical academy, St-Petersburg, Russia

    hematological, clinical and cytological diagnosis procedures

  • 11 months, Aug 1996 - Jun 1997

    Clinical lab diagnostics

    Medical academy, St-Petersburg, Russia

  • 5 years and 11 months, Aug 1990 - Jun 1996

    Human medicine and prophylaxis

    Medical academy, St-Petersburg, Russia

Sprachen

  • Russian

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    C1 (Fließend)

  • English

    C1 (Fließend)

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