Education:
- Study of Veterinary medicine 1997 – 2003, Ludwig-Maximilians University, Munich
- Doctoral thesis 2004 – 2006, Institute for Medical Microbiology, Infectious and Epidemic Diseases, veterinary faculty of the LMU, Munich
Professional Experience:
| Since 2022 | Senior Consultant SCRATCH Pharmacovigilance GmbH & Co. KG |
| 2015 – 2022 | Head of department / scientific assistant at the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn with focus on ICSR-Processing and databases, EudraVigilance, signalling, and assessment of switch-requests; responsible for any database changes/process adaption associated to the implementation of “Simplified Reporting” modalities/Go-life of EudraVigilance in 2017; participation in inspections as an expert for ICSR-Processing / databases and signalling; representative of the BfArM in various European working groups discussing regulatory (including adaptation of the ICH E2B(R3)-standard for Europe; revision of GMP VI and IX; revision of ICH E2D etc.) as well as practical (revision and maintenance of the IME list; ICSR exchange with and signal detection in EudraVigilance etc.) aspects of European Pharmacovigilance; contact for national stakeholders. |
| 2008 – 2015 | Various positions at MedPharmTec GmbH, Munich, in the areas of labelling and pharmacovigilance with a focus on medical writing and signal assessment |
| 2006 – 2008 | Postdoc position at Institute for Medical Microbiology, Infectious and Epidemic Diseases, veterinary faculty of the LMU, Munich |
Miscellaneous:
- Experience in pharmacovigilance, esp. ICSR-Processing, data analysis and signalling
- Experience in the preparation of Rx-OTC switch requests
- Knowledge of regulatory decision-making process
- Experience in interdisciplinary and multinational communication and co-operation, working in transnational committees as well as stakeholder management
- Management experience (up to 20 employees)
- Inspection experience
- Design and implementation of pharmacovigilance databases
- Experience in training and scientific writing/publication
- Qualified for the function of “Vet-QQPV” and “veterinary assistance”, respectively, according to Art. 78 Reg (EU) 2019/6 and Art. 3 Implementing Regulation (EU) 2021/1281
qualified for the function of the „local/regional responsible person“ according to Art. 77(8) of Regulation (EU) 2019/6
About myself:
Raised in an extended family with ancestors from all over Europe, with relatives on four continents and, perhaps the biggest challenge, as a “second mommy”, I know how important it is to talk and – even more – to hear what people actually say.
My motto for my work at SCRATCH derives from my grandmother: Accompanied by bright eyes and a smile from the bottom of her heart, she made every customer coming into my family’s store becoming part of this family, just by saying the following two words:
‘Wonderful Welcome!‘
