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.

• Bachelor’s Degree, Registered Nurse or Pharmacist / Registered Diploma or Associate Degree Nurse with preferred 3 years experience,
• Knowledge of ICH/FDA regulations, guidelines affecting drug safety issues,
• Ability to understand product labelling/literature,
• Clinical knowledge to apply to adverse event data collection and assessment,
• Computer proficiency,
• Data analysis, synthesis, problem solving and time management skills,
• Good communication skills in English, both written and verbal,
• Good team player and flexible to work on diverse projects in various disease areas.

The position can be based in Waterloo (Belgium) or Paris (France).