Anja Theumer
Clinical Affairs Manager at Dosing Gmbh - A Dedalus Company
Based in Heidelberg, Germany
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Seniority
Manager
Department
Operations
Location
Heidelberg
Industry
Information Technology and Services
Company size
30
Contact information
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a•••••••@dosing-gmbh.de
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Background
About Anja Theumer
More than 7 years of experience in Pharmacovigilance & Patient Safety * As a Clinical Affairs Manager responsible for the Clinical Evaluation of Software as a Medical Device under MDR, CDSS for the administration and dosage of medications, Post Market Surveillance and Risk Management * As a Manager of Safety Regulatory Intelligence responsible for compilation, maintenance, and distribution of the country-specific regulatory requirements for expedited and aggregate reporting of safety information for drugs (incl. biologics and vaccines) as well as medical devices * QPPV and RMP requirements * As a Drug Safety Associate served as a Safety Lead on various complex projects (phase with global expedited and periodic safety reporting and case processing tasks * Experience in mentoring and training of new or less experienced team members globally on general and process-specific tasks (mentorship)* Broad knowledge about the principles of the ICH-GCP guidance as well as ethical and legal frameworks of clinical trials (MDR, Clinical Trial Regulation 536/2014 (EU CTR), Clinical Trial Directive 2001/20/EC)
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