Dimitri Soumailakakis
Angestellt, Senior Global Pharmacovigilance Operations Specialist, Bausch Health Companies
Berlin, Deutschland
Werdegang
Berufserfahrung von Dimitri Soumailakakis
Bis heute 9 Jahre und 9 Monate, seit 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 Monate, 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 Monate, Aug. 2013 - Nov. 2013
CRA II
Covance/ Sanofi Aventis
On-/ Off site monitoring
6 Monate, Feb. 2013 - Juli 2013
Drug Safety Officer
IOM Tech
Drug Safety /MedDRA Coding Service, Inspection & Audit Preparation Service
2 Jahre und 6 Monate, 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 Monate, Dez. 2009 - Juni 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 Monate, März 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 Monate, 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 Jahr und 5 Monate, Nov. 2006 - März 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
Englisch
Fließend
Deutsch
Muttersprache
Griechisch
Muttersprache