EDUCATION:
Study of pharmacy at the University of Vienna, graduated with success

Diploma thesis “Synthesis of non cancerogenic, bifunctional isoindol derivatives“, graduated with excellent success

SKILLS / WORKING SCOPE:

REGULATORY AFFAIRS:
- CTD, e-CTD, NTA management
- e-submission / CESP
- XEVMPV management
- Module 1 management
- Module 3 / CMC management
- Lifecycle management (variations, renewals)
- New submissions (national/DCP/MRP/central)
- Deficieny letter management
- Labelling, SmPC, PIL, QRD, readability testing
- Generics
- Orphan drugs / compassionate use
- Falsified medicines
- Parallel distribution
- Regulatory strategies / fees – evaluation, investigation
- Regulatory legislation consulting (BASG, EMA, AMG)
- OTC, medical devices, dietary supplements, differentiation, health claims

PHARMACOVIGILANCE / DRUG SAFETY:
- EU-QPPV / deputy QPPV
- Case evaluation, medical assessment, reporting
- Data entry / validation (e.g. ArisG)
- MedDRA Coding
- PSUR management
- SDEA management
- Narrative writing
- PSMF management
- PV-SOPs management
- Pharmacovigilance legislation consulting (GVP, EMA, AMG)

MEDICAL SERVICES:
- Medical translations, revisions, proofreading (patient faced, expert faced, study synopsis, ICF, scientific training material, Regulatory/PV documents, SmPCs, PILs etc.)
- Scientific literature research (Medline)
- Scientific investigation
- Medical information for doctors, apothecaries and patients
- Medical / PV training for staff/field sales
- Compilation of scientific/medical information (e.g. training documents)