Our client, a leading global CRO, provides a comprehensive range of services in Phase I-IV clinical trials to the biopharmaceutical and device industries. They are currently seeking a Drug Safety Administrator for the Hesse region in Germany.
The Drug Safety Administrator will be responsible for ensuring all safety system activities are completed in accordance with procedures, as well as other applicable regulations. They will also coordinate and monitor safety system set up activities for all projects.
PRINCIPAL RESPONSIBILITIES include:
Ensuring all safety system activities involving ARISg or other safety systems are completed in accordance with SOPs, SSPs and other applicable regulations
Coordinating and monitoring safety system set-up activities for all projects
Responsible for validation exercises/test script testing for applicable safety systems as required
Configuration of study databases to include installation and report parameters as well as code-list and validation configuration based upon individual study needs
Maintain Company Drug, Protocol, Laboratory, Labeling, and any other study specific dictionaries
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree or equivalent education
Understanding and interest in technical and IT solution
Advanced working knowledge of safety systems and/or other databases
PERSONAL SKILLS & ATTRIBUTES:
Advanced skills in data retrieval
Excellent computer skills
Excellent English verbal and written communication skills
BENEFITS OF THE ROLE: This company has an outstanding track record with a style of work that has been rated as the highest in the in the industry. They are committed to providing all the assistance and support you require to enable you to reach your goals. Salaries are competitive and they offer an excellent benefits package including financial and long service awards.
Fforde is acting as a recruitment agency/business.
KEYWORDS: Drug Safety, Clinical Research, Clinical Trial, Clinical Study, Clinical Monitoring, Clinical, Medical, Science, Nursing, Pharmacy, Medicine, IT, ARISgTM, ARGUS, Oracle, MS, SQL Server, T-SQL, IT, Pharmaceutical, CRO, Hesse, Germany, Europe
Posted: 31/07/2012 | NPJ Ref: 84541