About Know-how

Responsibility – Client

PV System Administrator

Merz, Frankfurt

Activities

Maintenance and improve clinical system

·    Manage changes of PV systems according GxP

·    User support.

Responsibility – Client

IT Clinical Operations Application System Manager

UCB, Monheim

Activities

Maintenance and improve clinical system

·    Manage changes of clinical systems

·     Improve and automate processes and systems

·    User support.

Responsibility – Client

Computer System Validator – Pharmacovigilance System –

Fresenius-Kabi, Oberursel

Activities

Validation of the Pharmacovigilance System

·    System Review and PQ Validation execution

·     Analyze validation issues in E2B, Metadata, Workflow and HL7, coordination with software provider to define fixes, consider product life cycle, Company Core Data Sheet, Labeling information

·    Write PQ Test scripts, user manuals and training materials.

Responsibility – Client

Pharmacovigilance Project Manager –

Merck, Darmstadt

Activities

Improve of the Pharmacovigilance Data Reconciliation Process

·    Design automated solution and planning of project considering GVP

·    Monitor development, testing, training and rollout

·    Implementation of the solution and monitor improvements

·    Develop related documentation

Responsibility – Client

Pharmacovigilance Manager –

Mallinckrodt, Bonn

Activities

PV AE evaluation, assessment and registration.

·    ICSR monitoring, registration incl. MEDRA-coding, case summary

·    Partner and Authority reporting

·    Evaluation of device related AEs

Responsibility – Client

Pharmacovigilance Consultant –

Sigma Tau, Rome (Italy)

Activities

·     Analysis of current process and define required changes and configurations according GVP. Define related monitoring reports.

Responsibility – Client

Pharmacovigilance Project Manager –

MEDA Pharma, Bad Homburg

Activities

Data migration of the Pharmacovigilance system data

·    Planning and coordinating of projects

·    Implementation of EMA business rules and guidance

·    Set-up migration plans and mapping rules

·    Data validation and develop related documentation

Responsibility – Client

Computer System Validation – Pharmacovigilance System

Bayer AG, Berlin

Activities

Validation of the Pharmacovigilance System

·    Review and execute OQ and PQ Validation

·    Analyze documentation and validation issues

·    Monitor test execution

Responsability – Client

Pharmacovigilance System Manager –

CSL BEHRING, Marburg

Activities

Maintaining of the Pharmacovigilance System

·    Change management and CSV

·     Verification of Company Core Data Sheet, Labeling information and track updates

·    Develop client enhancements

Responsability – Client

Pharmacovigilance Manager –

Abbvie Wiesbaden

Activities

Case registration in Pharmacovigilance System

·    Register serious and non-serious cases

·    Compose case narrative

·    Evaluation and validation

Responsability – Client

Product Manager for PV-Data Base –

Extedo GmbH, Ottobrunn

Activities

Development of the Pharmacovigilance System

·    RAVE – PV-System Data Interface Implementation at client side

·    Set-up CDISC to E2B data format transformation rules

·    EMA business rules and guidance implementation

·    Software development and Product Life Cycle Management

·    Develop related documentation and user guidance

Responsability – Client

Project Manager –

Extedo GmbH, Ottobrunn

Activities

Facilitate client process to switch to PcVmanager

·    Analysis of client PV Processes and define changes according GVP

·    Design Data Migration

·    Prepare user requirement specification and other documentation

·    Computer System Validation, Maintain CAPA system

Responsability – Client

Development Manager for CTMS –

Pharmalog, München

Activities

Improve Clinical Trial Management System

·    Develop new functionality and enhancements

·    CTMS Maintenance, CRF tracing and CAPA introduction

·    Correct data issues