Susanne Kienzle-Horn, M.D.
Senior Consultant
SCRATCH Pharmacovigilance GmbH
Schlossstrasse 19
D-35510 Butzbach
Germany

Tel.: +49 6033 745 35 50
Fax: +49 6033 745 35 59
Mobile: +49 163 600 6690
email: kontakt(at)scratch-pv.com
Homepage: www.scratch-pv.com

 

Education

  • Diploma in Pharmaceutical Medicine 2003, ECPM, Basel
  • Diploma in Informatics 1990, Technical University Berlin
  • Medical qualification (approbation) 1985, Free University Berlin

Professional experiences

  • Since 2001 (Senior) Consultant SCRATCH Pharmacovigilance GmbH, Butzbach
  • 1998 – 2001 Head of Drug Safety, Merz + Co, Frankfurt
  • 1994 – 1998 Head of Clinical Safety and GCP, Head of Clinical Monitoring, Medical Director, Director of Safety Operations, Europe, Head of Clinical Operations; Euro Bio-Pharm, Bad Soden
  • 1992 – 1994 Medical Project Leader, vice „Stufenplanbeauftragte“, Marion Merrell Dow, Rüsselsheim
  • 1990 – 1992 Marketing Assistant, IMS, Frankfurt

Own company

  • SCRATCH Pharmacovigilance is a full-service provider for Pharmacovigilance, with documented experience in all its aspects – actually, more than 25 years of experience ranging from setting up a PV system, case and report management, inspections/audits, risk management plans, and including risk situations and recalls.
  • SCRATCH Pharmacovigilance stands for Safety Competence, Risk Assessment, Training, and Consulting with Heart.

Ambition

Your PV health is our objective.

SCRATCH Pharmacovigilance started in 2001 as a concentrated mono substance. Soon, an excipient was added for increased efficacy and improved efficacy onset. An innovatively restructured, highly effective and safe combination product was authorized in 2008, indicated for Pharmacovigilance related deficiencies and disorders.

Clients taking SCRATCH Pharmacovigilance report immediate relief of the most pressing symptoms. It may also be taken long term for chronic PV disease with individualized dosage regimen. In some cases, it has served well as a nutritional supplement to enhance and catalyze existing structures and processes.

Typical projects

  • Services of a Qualified Person for Pharmacovigilance (QPPV) and deputy
  • Implementation, operation and maintenance of a PV system, including SOPs
  • Case Management, incl. data basing, follow up, and reporting
  • Creation/review of summary reports, e.g. Periodic Safety Update Reports
  • Detailed Description of PV System (DDPS); Risk Management Plans (RMPs)
  • Responding to regulators safety requests, e.g. EU referrals
  • PV related audits (e.g. due diligence) and support around PV inspections
  • Interim PV management or operational support
  • PV related training and risk simulations
  • Management coaching / strategic PV consultancy