Alla Axelbant

Angestellt, Senior Specialist Pharmacovigilance, Otsuka Novel Products GmbH

München, Deutschland

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

  • Bis heute 2 Jahre und 2 Monate, seit Mai 2022

    Senior Specialist Pharmacovigilance

    Otsuka Novel Products GmbH

  • 3 Jahre und 3 Monate, März 2019 - Mai 2022

    Drug Safety Specialist

    Otsuka Novel Products GmbH

  • 9 Monate, Juni 2018 - Feb. 2019

    Drug Safety Department (Otsuka Novel Product GmbH) via Cromsource

    Otsuka Novel Products GmbH

  • 1 Jahr, Jan. 2017 - Dez. 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 Monate, Jan. 2016 - Apr. 2016

    Training period as Drug Safety Officer (Pharmacovigilance)

    Dr. Notghi Academy, Berlin

  • 7 Jahre und 3 Monate, Okt. 2007 - Dez. 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 Monate, Juni 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 Monate, Nov. 2002 - März 2003

    Training periods as Medical Statistician

    Coordination center for clinical studies in the university clinic of Düsseldorf

  • 2 Jahre und 2 Monate, Sep. 1997 - Okt. 1999

    doctor for clinical lab diagnostics

    hospital No. 144, St-Petersburg, Russia

Ausbildung von Alla Axelbant

  • 7 Monate, Okt. 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 Monate, März 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 Jahr, Feb. 2002 - Jan. 2003

    Medical informatics

    mibeg-Institute Cologne

    Certificate in medical informatics, SAS, SPSS, MS Office

  • 2 Monate, Sep. 1999 - Okt. 1999

    Clinical lab diagnostics

    Medical academy, St-Petersburg, Russia

    cytological diagnoses for samples taken via endoscopies and puncture tests

  • 3 Monate, Okt. 1997 - Dez. 1997

    Clinical lab diagnostics

    Medical academy, St-Petersburg, Russia

    hematological, clinical and cytological diagnosis procedures

  • 11 Monate, Aug. 1996 - Juni 1997

    Clinical lab diagnostics

    Medical academy, St-Petersburg, Russia

  • 5 Jahre und 11 Monate, Aug. 1990 - Juni 1996

    Human medicine and prophylaxis

    Medical academy, St-Petersburg, Russia

Sprachen

  • Englisch

    Gut

  • Deutsch

    Fließend

  • Russisch

    Muttersprache

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