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

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📌 Clinical Drug Safety Officer (Barcelona)
🏢 Grifols
📍 Barcelona