Dr. Heike Duerr
IT
MS-Office
Expert knowledge
Adobe Acrobat
Advanced knowledge
First Doc
Advanced knowledge
Argus Drug Safety Database
Advanced knowledge
SharePoint
Good knowledge
Cognos
Good knowledge
Language
German
Native speaker
English
Cambridge Proficiency Grade A
French
Basic Skills
Latin
Basic Skills
Memberships
EMWA
European Medical Writers Association

Profile

PhD in Molocular Neurobiology

Medical writing experience since 5 years

  • CSRs for Phase 1-4 studies, Lay summaries, Investigators Brochures
  • CTD Modules 2.5 and 2.7
  • Writing and/or editing manuscripts for publication, preparing posters and presentations for scientific meetings
  • Entering study results into EudraCT

Pharmacovigilance specialist for 11 years

  • Reviewing drug safety relevant clinical trial documents and providing Pharmacovigilance Input in Clincal Trials
  • MedDRA coding
  • Review of individual case reports
  • Safety signal evaluation
  • Writing Risk Management Plans
  • Writing periodic safety reports such as: DSURs, Annual Safety Reports, assessment reports for bi-annual SUSAR listings, PSURs.
  • Presentation at Investigator’s Meetings
Career History
Founder, Senior Medical Writer
Lahn Pharma Services GmbH, Limburg a.d. Lahn, GermanySince 09/2018
Senior Medical Writer
Mundipharma Research GmbH & Co KG, Limburg, Germany09/2015 – 09/2018
Medical Writer
Mundipharma Research GmbH & Co KG, Limburg, Germany08/2013 – 08/2015
  • Writing and/or editing documents for clinical studies and submission to regulatory agencies:
    – CSRs for Phase 1-4 studies
    – Lay summaries
    – CTD Modules 2.5 and 2.7
    – Investigators’ Brochures
  • Writing and/or editing manuscripts for publication, preparing posters and presentations for scientific meetings
  • Tracking timelines for the creation of these documents
  • Reviewing and editing scientific documents prepared in Medical Research, incl. Clinical Protocols and
  • Statistical Analysis Plans
  • Entering study results into EudraCT
  • Serving as Medical Writing expert on Clinical Sub-teams
  • Training of new employees
Principal Investigational Drug Safety Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany01/2011 – 07/2013
Senior Investigational Drug Safety Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany09/2009 – 12/2010
European R&D Investigational Drug Safety Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany10/2003 – 08/2009
Drug Safety and Pharmacovigilance
Mundipharma Research GmbH & Co KG, Limburg, Germany05/2002 – 10/2003
  • Setting up Investigational Drug Safety
  • Head of International Investigational Drug Safety working group
  • Advise in safety issues during clinical trials
  • Serving as drug safety expert in Company assigned committees about harmonisation of study reports, assessment of new studies, upper and lower limits of laboratory values, and others
  • Presentation at Investigator’s Meetings
  • Reviewing drug safety relevant clinical trial documents
  • Writing periodic safety reports such as: DSURs, Annual Safety Reports, assessment reports for bi-annual SUSAR listings, PSURs
  • Writing Risk Management Plans
  • Safety signal evaluation
  • Review of individual case reports
  • MedDRA coding
  • SOP writing
  • Training of new employees
Medical Information and Documentation
Mundipharma Research GmbH & Co KG, Limburg, Germany05/2000 – 04/2002
  • Medical Writing
  • Editing product information (SmPC, patient information sheets, product information in drug compendia)
  • Literature search, review and summary of results
  • Replying to scientific queries