
Ozlem Karaosmanoglu Aksoy
Throughout my in Drug Safety, Quality Assurance I have remained a motivated person who enjoys the stimulation of... | Miami, Florida, United States
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Ozlem Karaosmanoglu Aksoy’s Emails oz****@he****.nl
Ozlem Karaosmanoglu Aksoy’s Phone Numbers No phone number available.
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Ozlem Karaosmanoglu Aksoy’s Location Miami, Florida, United States
Ozlem Karaosmanoglu Aksoy’s Expertise Throughout my in Drug Safety, Quality Assurance I have remained a motivated person who enjoys the stimulation of problem-solving and I believe my tenacity and innovative approach helps to achieve results. I am keen to ensure that the smooth development and introduction of new systems always, along with the training and management of the department keep pace with the continuing demands imposed by Good Pharmacovigilance Practice, Good Distribution Practice, Good Manufacturing Practice and Good Clinical Practice. Although an open and friendly team leader, player, I am also a self-starter committed to completing projects on time. Extensive background in Quality assurance to ensure that the product or service an organization provides is fit for purpose and meets both external and internal requirements, including legal compliance and customer expectations. I have been working in the pharmaceutical industry for more than a decade and have held roles of increasing responsibility with Yamanouchi, Astellas, Boston Scientific, Analytico, Medinet, EZEM, Sanofi Aventis, Organon, Genzyme, and Abbott and since 2011 with Amgen across Quality Control, Quality Assurance, Pharmacovigilance, and Compliance. Extensive background in the Pharmacovigilance to oversight of operational, maintenance and compliance of the Pharmacovigilance System; the evaluation of the safety profile and benefit-risk detection, assessment, and management of marketed products and products under development; write and review drug safety (periodic) reports; communicate new safety information to the competent authorities and act as the primary point of contact. Specialties: Pharmacovigilance, Quality assurance, Training, Preparation for inspections, Performing Audits, Setting up affiliates, Writing technical reports ( PSURs, ASR, SOPs/POLs, protocols ), Managing people, Good Distribution Practice, Good Manufacturing Practice, Biochemistry, Qualified Person (PV/QA).
Ozlem Karaosmanoglu Aksoy’s Current Industry Amgen
Ozlem
Karaosmanoglu Aksoy’s Prior Industry
Leiden University
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Yamanouchi
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Astellas Pharma
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Yacht Technology
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Boston Scientific
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Analytico Medinet
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Ezem
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Sanofi Aventis
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Organon
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Genzyme
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Abbott
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Amgen
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Work Experience

Amgen
Director Final Product Technologies Quality
Sat Aug 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Amgen
Director Of Quality Assurance
Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Aug 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Amgen
Director International Quality
Sun Mar 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Aug 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Amgen
Director International Quality
Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Amgen
Senior Quality Assurance Manager
Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott
Pharmacovigilance Consultant
Fri Oct 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Genzyme
Pharmacovigilance consultant
Sat Mar 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Organon
Compliance consultant
Wed Aug 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Mar 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Sanofi Aventis
Training and Compliance Manager
Sun Apr 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Ezem
Pharmacovigilance & Quality Assurance Manager
Sat Apr 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Apr 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Analytico Medinet
Interim Professional study manager
Tue Nov 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Boston Scientific
Interim Professional-Senior Medical Research Associate
Fri Apr 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Yacht Technology
Senior IP
Tue Mar 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Mar 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Astellas Pharma
Pharmacovigilance specialist
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Feb 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Yamanouchi
Interim Professional project consultant
Tue Jul 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Dec 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Leiden University
student/trainee
Wed Jan 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)