Katharina Stolar

Angestellt, Corporate Druge Safety Officer, Octapharma Pharmazeutika Produktionsges.m.b.H.
Wien, Österreich

Fähigkeiten und Kenntnisse

flexibility
reliability
independent
organized
Teamwork
enthusiasm
English Language
willingness to learn

Werdegang

Berufserfahrung von Katharina Stolar

  • Bis heute 6 Jahre und 5 Monate, seit März 2019

    Corporate Druge Safety Officer

    Octapharma Pharmazeutika Produktionsges.m.b.H.

    - Proecessing of post-marketing and clinical safety information into safety reports and submission to health authorities - Maintaining the global drug safety database - Providing pharmacovigilance training to other employees - Liasing with pharmacovigilance personnel (local & worldwide), other departments and authorities - Participating in the maintenance of the pharmacovigilance quality system - Supporting implementation of OctaDSD (Database)

  • 1 Jahr, Okt. 2017 - Sep. 2018

    Corporate Trainee Clinical Quality Assurance

    Octapharma Pharmazeutika Produktionsges.m.b.H.

    - Maintenance of the SOP System in CR&D - Manage the CR&D Training Program - Assist in preparation, conduct and follow up of regulatory inspections - Support Management of contractors - Support continuous improvement at CR&D - Perform QC Review of clinical documents

  • 1 Jahr und 1 Monat, Sep. 2016 - Sep. 2017

    Corporate Drug Safety Officer

    Octapharma Pharmazeutika Produktionsges.m.b.H.

    - data entry and correction of international case safety reports (ICSR) in a Access based database - QC check of not valid and safety relevant literature ICSRs - updating of the international contact network with local drug safety officers (LDSO) - sending of non-serious and not valid ICSRs to international LDSOs - archiving in Iron Mountain - writing and reviewing of standard operation procedures (SOP) in English language - Monthly Reconciliation of ICSRs with the LDSOs

  • 4 Jahre und 6 Monate, März 2012 - Aug. 2016

    Corporate Drug Safety Assistant

    Octapharma Pharmazeutika Produktionsges.m.b.H.

    - data entry and correction in Microsoft based database - Quality check of international case safety reports (ICSR) (literature) in the database - Monthly Reconciliation of ICSRs with international local drug safety officers (LDSO) - saving, scanning and archiving of ICSRs and periodic safety update reports (PSUR) in Iron Mountain - sending of non-serious and not valid ICSRs to international LDSOs - Training for students during Internship in the department

Ausbildung von Katharina Stolar

  • 4 Monate, Okt. 2018 - Jan. 2019

    Sinology

    University of Vienna

  • 1 Monat, Sep. 2016 - Sep. 2016

    Working Abroad - New Zealand

    - maintaining the garden - doing household chores - helping milk cows

  • 2 Monate, Aug. 2015 - Sep. 2015

    Working Abroad - South Korea

    - english lessons for the members - helping with the preparation and clean up of the stage - weeding in the rice paddy

  • 2 Jahre und 9 Monate, Okt. 2013 - Juni 2016

    Koreastudien/ Ostasienwissenschaften

    Universität Wien

    korean identity, land reclamation and history of big companies in comparison to their japanese counterparts

  • 2 Monate, Juli 2013 - Aug. 2013

    Working Abroad - Japan

    - cleaning in the carpentry shop - helping out in the restaurant - doing household chores - teaching english to elementary school children - maintaining the organic vegetable farm (weeding, planting etc.) - packing vegetables for selling in the market

  • 3 Jahre und 9 Monate, Okt. 2011 - Juni 2015

    Japanstudien/Ostasienwissenschaften

    Universität Wien

    background of suicide in Japan - a short summary, minorities in Japan and their organisations

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Koreanisch

    Grundlagen

  • Japanisch

    Grundlagen

  • Chinesisch

    Grundlagen

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