Dimitri Soumailakakis

Angestellt, Senior Global Pharmacovigilance Operations Specialist, Bausch Health Companies
Berlin, Germany

Fähigkeiten und Kenntnisse

Clinical Studies/ Clinical Trial Posting
Investigator Brochure Management
Drug Safety/Pharmacovigilance
Clinical Monitoring/ Clinical Logistics
Medical Devices
ICH-GCP
GMP
Oncology R&D
Consulting Biotechnology
Project Management
Wastewater Plant Biotechnology
Bioengineering Cloning
Fermentation
Protein Production and Purification
Protein Chemistry
Bioinformatics
Bioanalytics

Werdegang

Berufserfahrung von Dimitri Soumailakakis

  • Current 11 years and 9 months, since Sep 2014

    Senior Global Pharmacovigilance Operations Specialist

    Bausch Health Companies

    Review and manages Third Party commitments especially Safety Data Exchange Aggreements and support maintenance of global list of Third Party Agreements Manage ICSR information

  • 8 months, Jan 2014 - Aug 2014

    Project Manager Clinical Trials

    AIO-Studien-gGmbH

    Planning and conducting clinical trials Selection, contracting and management of CRO’s and third-party vendors Budgeting clinical trials

  • 4 months, Aug 2013 - Nov 2013

    CRA II

    Covance/ Sanofi Aventis

    On-/ Off site monitoring

  • 6 months, Feb 2013 - Jul 2013

    Drug Safety Officer

    IOM Tech

    Drug Safety /MedDRA Coding Service, Inspection & Audit Preparation Service

  • 2 years and 6 months, Aug 2010 - Jan 2013

    CRA/Drug Safety Officer/Clinical Trial IB Manager & Posting Officer

    Dr. Notghi CRO/Bayer Pharma AG

    Clinical Research Associate (Jul2012-Jan2013): On/Off-site Cinical Monitoring, Study Start Up, Data management Drug Safety Officer (Jan2011-Jun2012): Quality control & case processing of incoming Individual Case Safety Reports (ICSRs) incl. databasing (ARGUS) writing narratives & MedDRA coding Investigator Brochure's Manager/Clinical Trial Posting Officer (Aug2010-Jun2011) Managing compliance of Investigator Brochures, Managing & posting of disclosable Clinical information on clinicalTrials.gov

  • 7 months, Dec 2009 - Jun 2010

    Drug Safety Specialist

    PAREXEL International GmbH, Berlin

    • quality control and processing of SAE case reports • writing case narratives and requesting follow up • data entry into safety database / tracking system

  • 9 months, Mar 2009 - Nov 2009

    Clinical Monitor/ Clinical Logistics Manager

    Parexel Akademie

    • regulatory and legal foundations of clinical trials • theory and practice of clinical monitoring and clinical logistics • pharmacology, biometrics and data management • business english, communication, presentation and negotiation • 3-month work placement in finance controlling at Clinical Logistics Services, Berlin, Germany

  • 11 months, Apr 2008 - Feb 2009

    Consulting Engineer, Biotechnology

    LAR Process Analysers AG

    • scheduling and supervising project implementation • developing and prototyping a biotechnological waste water analyze system

  • 1 year and 5 months, Nov 2006 - Mar 2008

    Clinical Trial Manager/ Clinical Research Associate

    IOM Tech GmbH

    • budgeting clinical trials • scientific consulting in customer support • SAE processing , line listings, • On/Off-site Cinical Monitoring • scheduling and organizing clinical trial meetings • improving quality assurance and managing trial data

Ausbildung von Dimitri Soumailakakis

  • Bis heute

    Biotechnologie

    Technical University Berlin

    Bioengineering ( Molecular-/ Microbiology, Up-/ Downstream Processing, Bioanalytics), Nutrition Technology

Sprachen

  • English

    C1 (Fließend)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • Greek

    C2 (Verhandlungssicher / Muttersprachlich)

XING – Das Jobs-Netzwerk

  • Über eine Million Jobs

    Entdecke mit XING genau den Job, der wirklich zu Dir passt.

  • Persönliche Job-Angebote

    Lass Dich finden von Arbeitgebern und über 20.000 Recruiter·innen.

  • 21 Mio. Mitglieder

    Knüpf neue Kontakte und erhalte Impulse für ein besseres Job-Leben.

  • Kostenlos profitieren

    Schon als Basis-Mitglied kannst Du Deine Job-Suche deutlich optimieren.

21 Mio. XING Mitglieder, von A bis Z