Clinical Drug Safety Officer

Grifols; Barcelona; À distance; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Grifols seeks a Clinical Trial Safety Scientist to contribute to safety data review from a home-based role in Spain. The position involves cross-functional collaboration with study physicians and trial teams to ensure medical accuracy and timely escalation of critical safety issues.

Responsibilities include data review, safety narratives, and participation in start-up activities. This is a full-time role supporting TRISARC deliverables within an extended study team.

Responsabilités

• Ensure consistent processes and efficient review of critical clinical/safety data
• Review patient-level clinical/safety data to ensure medical accuracy and coding consistency
• Prepare aggregated data visualization and facilitate meetings related to safety data review
• Contribute to study start-up activities and input to documents/tools setup
• Serve as a member of the Extended Study Team and report on TRISARC deliverables
• Work with study physicians/clinical scientists to support standardized data review and medical evaluation
• Escalate urgent medical cases to the study physician/medical scientist as appropriate
• Provide input into automated patient narratives and handwritten narratives processes
• Lead quality of own deliverables
• Take on tasks assigned by Directors/Associate Directors Clinical Trial Safety
• Provide input into non-drug project work including training and procedures development

Description du poste

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