Imperia - Drug Safety Services
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Pharmacovigilance - Compliance - Quality Control

Anja Klaus - Chief Executive Officer


Since 07/2016       

CEO

Imperia – Drug Safety Services

04/2016– 09/2016      

Compliance Specialist Mallinckrodt, Germany

  • Single case reconciliation with Safety partners worldwide concerning the timely submission of Individual Case Safety Reports to Mallinckrodt Global Pharmacovigilance and national Competent Authorities
  • Monitoring of Global Pharmacovigilance performance concerning the timely submission of Individual Case Safety Reports to Competent Authorities and Safety Partners
  • Identification, tracking and handling of late cases and necessary exceptions including management of Corrective and Preventative Actions
  • Performance Monitoring according to Mallinckrodt’s processes of Aggregate Safety Reports submissions, Safety Variation submissions, Signal Processing

12/2015– 04/2016

Assistant CEO AtaX Advise, Germany 

  • Optimize Excel and Powerpoint
  • Training MR

11/2010– 06/2016       

Projectmanager (Freelancer) Digital Agengy

  • Determine, document and manage project scope, goals, timelines and milestones
  • Quality Control
  • Advice existing clients

Since 08/2003               

CEO Büroservice Klaus

  • Telemarketing
  • Accounting
  • Invoicing
  • Revision Status
  • Database maintenance
  • Scheduling

08/2002– 07/2003

Maternity leave

07/1999– 07/2002    

Office Management Assistant - Moving company Klaus

08/1997– 06/1999     

Completed vocational training: Office Management Assistant

10/1996– 07/1997      

Office Management Assistant - Moving company Klaus

07/1992– 09/1996     

Office Management Assistant - Various companies

08/1991– 06/1992     

University of applied sciences entrance qualification Berufskolleg Bad Saulgau

09/1989– 07/1991      

Completed vocational training: Bundesbahnassistentin Deutsche Bahn

09/1988– 07/1989     

Practical work - bfz Ravensburg

06/1988                        

Secondary School certifficate - Realschule Aulendorf


Qualifications

 

Language skills      

German
English

mother tongue
business fluent (level C2)


Computer skills

  

  • Microsoft Office (Word, Excel, Power Point) 
  • Adobe Acrobat, Photoshop
  • ARGUS database, Trackwise, PVQ

Technical skills

  • Project initiation, planning and the implementation in cooperation-based networks for digital projects
  • Organization of workshops und meetings including chairmanship, minutes and final report
  • Pharmacovigilance: drug safety, case processing, query management, reconciliation with world-wide partners, medical coding, medical translation, late case processing, exception and CAPA management, all in regard to clinical trials, post-marketing studies and spontaneous reports. ARGUS database

Special courses

  • Communication Skills
  • Training of Public Speaking
  • Basics of Project Management