Clinical Drug Safety Officer

Clinical Trial Safety Scientist (FSP - Permanent Home Based)  Madrid, Spain
Barcelona, Spain
Full time
R
Responsibilities
Ensure consistent processes and efficient review of critical clinical/safety data
Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level
Contribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents, tools set up)
Serve as a member of the Extended Study Team and report on TRISARC deliverables
Work with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation
Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate
Provide input into the process of setting automated patient narratives, if applicable
Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable
Lead quality of own deliverables
Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety
Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed