Working languages:
English to German

Markus Waismayer

Wien, Wien, Austria
Local time: 04:14 CET (GMT+1)

Native in: German (Variant: Austrian) Native in German
  • Send message through ProZ.com
Feedback from
clients and colleagues

on Willingness to Work Again info
No feedback collected
Account type Freelance translator and/or interpreter
Data security Created by Evelio Clavel-Rosales This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
Services Translation, Editing/proofreading, Project management
Expertise
Specializes in:
Medical (general)Biology (-tech,-chem,micro-)
Chemistry; Chem Sci/EngBotany
Science (general)

Experience Registered at ProZ.com: May 2017.
ProZ.com Certified PRO certificate(s) N/A
Credentials N/A
Memberships N/A
Software Adobe Acrobat, Wordfast
Bio
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)


Profile last updated
Aug 22, 2017



More translators and interpreters: English to German   More language pairs



Your current localization setting

English

Select a language

All of ProZ.com
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search