Dr. Stephan Gosten
Founding Partner and Managing Director
Stephan is a renowned expert in the field of computer system validation and a sought-after pharmaceutical consultant. As a founding partner and managing director of Argus Consult GmbH, he has many years of experience and extensive expertise in these fields.
With an impressive academic background and a passion for innovative technologies, Stephan has led numerous projects to success, particularly in the field of computer system validation. His in-depth understanding of regulatory requirements and extensive know-how enable him to develop customized solutions that meet the individual needs of his clients.
Stephan stands out not only for his expertise, but also for his ability to explain complex issues in an understandable way and to find pragmatic solutions. His clients appreciate his professionalism, his reliability and his ability to find effective solutions.
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Dr. Alexis Kasaras
Senior Pharma Consultant
Molecular Biologist
Alexis is a molecular biologist with more than 13 years of experience in research and project management in Germany, France and the USA. In 2012, he successfully completed his PhD in his field of training. After training as Drug Safety Officer/Clinical Trial Specialist, he further extended his expertise while working as Regulatory Affairs manager. He is business fluent in German, English and French.
Alexis has acquired extensive expertise in both regulatory affairs and pharmacovigilance in recent years. Since the beginning of 2019 he has been working in the field of pharmacovigilance with a focus on the validation of IT systems (CSV). He has gained particular expertise in the area of change and lifecycle management with the Oracle side-effect database Argus Safety.
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Eduardo Vieyra
Senior IT & Pharma Consultant
Biotechnologist
Eduardo completed his Master of Science in the field of biotechnology. Not least because of his chosen focus on bio-informatics, he already has a wealth of experience in programming complex applications and database analysis. As a long-standing tutor, he is also familiar with a wide variety of methods for imparting knowledge and the need for careful documentation to derive and verify work results. He is business fluent in German, English and Spanish.
Eduardo works for us in the field of pharmacovigilance with a focus on the validation of IT systems (CSV). His expertise lies in the areas of risk analysis, process optimization and documentation of digital systems. He has acquired special expertise in the use of the Oracle side-effect database Argus Safety.
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Mónica Gómez Monzesino
Junior Pharma Consultant
Molecular Biologist
Mónica completed her Master of Science in the field of biotechnology at the beginning of 2020. Since then, she gathered over 3 years of project and professional experience. Initially, she worked in the field of microbiological quality control, where she was responsible for method validation and LIMS system validation.
Since the beginning of 2022, Mónica has been an integral part of our team, specialized in pharmacovigilance with a focus on the validation of IT systems (CSV). Her key competences lie in the areas of risk analysis and documentation of digital systems. She has developed particular expertise in working with the Oracle adverse drug reaction database Argus Safety. Mónica's fluency in English, Spanish, and German enables her to effectively communicate with colleagues and stakeholders in a multilingual environment.
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CHahrazad Czwink
Pharma Consultant
Molecular Life Scientist
Chahrazad brings with her two years of project and professional experience since completing her Master of Science in the field of biotechnology. She initially worked as a research assistant at the TU Berlin in cooperation with a start-up in the field of 3D bioprinting, where she was responsible for quality control and setting up 3D bioprinting processes.
Since autumn 2022, Chahrazad has been a valuable member of our team in the area of pharmacovigilance with a focus on the validation of IT systems (CSV). She has developed a deep understanding of the Oracle adverse event database Argus Safety and possesses expertise in all aspects of system life cycle management and maintaining of documentation required for inspections. She is fluent in English, German, French and Arabic.
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