Frauke Uchtmann

• Assessment of pharmacovigilance (GVP) and / or GCP- systems and processes including interfaces with other departments and affiliates as well as contract partners of clients • Expert for GVP and GCP related questions within the department as well as for customers, national and international regulatory authorities • Operational steering of the pharmacovigilance department

• Assessment of pharmacovigilance (GVP) and / or GCP- systems and processes including interfaces with other departments and affiliates as well as contract partners of clients • Performing audits as lead- or coauditor • Steering of projects in the field of Quality Management and Compliance Services • Creation and implementation of corrective action(s)

Internal advisor for QM concerning all PV and/or GCP procedures External consultant for assessment, QA and improvementof PV and/or GCP systems and processes.

•Conduct of system, process and vendor audits •Preparation/review of Standard Operation Procedures (including publishing the electronic document management system) •Audit databases and study conduct (Trial Master File) •Preparation and hosting of sponsor audits •Consultancy of the project team in ICH/GCP and/or 21 CFR Part 11 or quality assurance relevant issues •Training of employees in ICH/GCP and 21 CFR Part 11 (introductory and refresher trainings)

•Audit/review of Trial Protocols, Case Report Forms, databases and study conduct (Trial Master File) •Preparation/review of Standard Operation Procedures (including publishing on the intranet/EDMS) •Conduct of system audits •Consultancy of the project team in ICH/GCP and/or 21 CFR Part 11 or quality assurance relevant issues •Communication and internal administration of laws and guidelines