The successful candidate will work closely with the Sponsor and the Clinical Data Management department in order to perform all activities related to the Safety Data Management of clinical trials.
- Perform ongoing systematic data compilation and initial review of safety information,
- Perform regulatory evaluation and assign causality and labeledness as applicable,
- Code cases using appropriate dictionary,
- Search and input data in electronic databases,
- Generate, track and resolve adverse event follow-up/ distribution correspondence,
- Manage adverse events reports from initial case and generate periodic reports; and other ad hoc reports,
- Prepare summary reports for internal and external use,
- Insure quality control of inputted safety data.
The position can be based in Waterloo (Belgium) or Paris (France).