Prof. Dr. Stefan Kaehler

Angestellt, Head of International Safety and Risk Management-EEA QPPV, Alnylam Pharmaceuticals
Wien, Austria

Fähigkeiten und Kenntnisse

Erfahrung im Internationalen Projektmanagement
Erstellung und Koordination von toxikologischen un
Erfahrung in Arzneimittelentwicklung
Zulassung
strategische Bewertung von Arzneimittelentwicklung

Werdegang

Berufserfahrung von Stefan Kaehler

  • Current 8 months, since Oct 2025

    Head of International Safety and Risk Management-EEA QPPV

    Alnylam Pharmaceuticals

  • Current 4 years and 8 months, since Oct 2021

    Exec Dir Qualified Person for Pharmacovigilance EU & UK

    Bristol Myers Squibb

  • 2 years and 6 months, Apr 2019 - Sep 2021

    Exec. Dir. II, Global Drug Safety & Risk Management, EEA-QPPV, GMP-QP

    Celgene International

    Serve as EEA QPPV, QPPV ARAB Region, QP Batch Release (all pharmaceutical forms including ATMPs marketed or clinical trial supply), Head Pharmacovigilance EU Big 5 & CEE Region (Czech Republic, Slovenia, Slovakia, Hungary, Poland, Estonia, Latvia, Lithuania, Serbia, FYROM…) and other EEA countries via matrix Lead. QPPV for ARAB-Region on behalf of Celgene Int Sarl. Responsible for total Budget and Workforce (FTE

  • 11 months, May 2018 - Mar 2019

    Exec. Dir., Global Drug Safety & Risk Management International, EEA-QPPV, GMP-QP

    Celgene International

    Serve as EEA QPPV, QPPV ARAB Region, QP Batch Release (all pharmaceutical forms including ATMPs marketed or clinical trial supply), Head Pharmacovigilance EU Big 5 & CEE Region (Czech Republic, Slovenia, Slovakia, Hungary, Poland, Estonia, Latvia, Lithuania, Serbia, FYROM…). QPPV for ARAB-Region on behalf of Celgene Int Sarl. Responsible for total Budget and Workforce (FTE)

  • 15 years and 6 months, 2003 - Jun 2018

    Lektor (Pharmakologie & Toxikologie)

    Universität Innsbruck
  • 11 months, Jun 2017 - Apr 2018

    Exec. Dir, Global Drug Safety & Risk Management International, EEA-QPPV, GMP-QP

    Celgene International

    Serve as EEA QPPV, QPPV ARAB Region, QP Batch Release (all pharmaceutical forms including ATMPs marketed or clinical trial supply), Functional Lead and Manager for EU big 5 Drug Safety Managers & CEE Region (Czech Republic, Slovenia, Slovakia, Hungary and Poland). QPPV for ARAB-Region on behalf of Celgene Int Sarl. Responsible for total Budget and Workforce (FTE) as Matrix Lead. Global Lead Safety Physician CAR T Cells ad interim (Jan 2018 to Mai 2018)

  • 1 year and 3 months, Mar 2016 - May 2017

    Executive Director, Global Senior Lead Safety Scientist (CAR T cells) & EEA-QPPV

    Celgene International

    Executive Director Global Lead Safety Physician/Scientist CAR T Cells, Global Business Development & Alliances, Global Drug Safety & Risk Management, EEA-QPPV, GMP-QP-Celgene Austria Drive safety science oversight and execution of Global Drug Safety and Risk Management Strategy including Business Alliances for all new Celgene compounds, Lead Safety Physician/Scientist responsible for CAR-T cells (i.e CD19 constructs) clinical development & Safety & Risk Management, serve as EEA QPPV and QP Batch Release

  • 7 months, Aug 2015 - Feb 2016

    Senior Director Global Risk Management Standards & GMP-QP EEA

    Celgene Europe Ltd, London, UK

  • 1 year and 1 month, Aug 2014 - Aug 2015

    Senior Director Global Risk Management Standards & EEA-QPPV; GMP-QP

    Celgene Europe Ltd.

  • 1 year and 4 months, May 2013 - Aug 2014

    Director Global Risk Management and QPPV, QP-Batch Release

    Celgene Europe Ltd

    Global Drug Safety & Risk Management

  • 2 months, Apr 2013 - May 2013

    Director Global Risk Management and dQPPV, QP-Batch Release

    Celgene Europe Ltd

    Global Drug Safety & Risk Management

  • 1 year and 10 months, Jun 2011 - Mar 2013

    Associate Director Risk Management Europe & APAC and dQPPV; QP Batch Release

    Celgene Europe Ltd.

    Global Drug Safety & Risk Management

  • 8 months, Nov 2010 - Jun 2011

    Senior Manager Global Risk Management Standards

    Celgene Europe Ltd

    QPPV-Office Global Drug Safety & Risk Management

  • 2 years and 6 months, May 2008 - Oct 2010

    Regulatory & Safety Manager, Quality Responsible Person (QP)

    Celgene

  • 9 years and 3 months, Feb 1999 - Apr 2008

    Head of Clinical Research, Development, Operations, Datamangement, Biometrics

    Gebro Pharma GmbH

  • 2 months, Dec 1998 - Jan 1999

    Univ. Assistent

    Universität Innsbruck

    Assistent mit Leitung einer Forschungsgruppe, Betreuung von Diplomanden und Doktoranten

  • 4 years and 2 months, Oct 1994 - Nov 1998

    Univ. Assistent

    Universität Innsbruck

    Dissertation im Fach Pharmakologie & Toxikologie, Univ. Assistent

  • 1 year and 1 month, Mar 1993 - Mar 1994

    Assistent

    Universität Innsbruck

    Assistent für pharmazeutisch-technologische Übungen, Gruppenleitung

Ausbildung von Stefan Kaehler

  • 1 month, Mar 2016 - Mar 2016

    Pharmakologie & Toxikologie

    Universität Innsbruck

    Priv. Doz.

  • 1 month, Apr 2011 - Apr 2011

    Leadership & Strategy in Pharmaceuticals and Biotech

    Harvard University Business School

  • 4 years and 2 months, Oct 1994 - Nov 1998

    Pharmakologie & Toxikologie

    Universität Innsbruck

  • 8 years and 1 month, Oct 1986 - Oct 1994

    Pharmazie

    Universität Innsbruck

    Pharmazeutische Technologie, Pharmakologie & Toxikologie

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • Spanish

    A1-A2 (Grundkenntnisse)

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