Senior Clinical Trial Safety Scientist (Permanent Home Based)
- Madrid
- Permanente
- Tiempo completo
- 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
- Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields
- Minimum 4+ years of experience in Pharmacovigilance / Drug Safety
- Understanding of the clinical study and drug development process
- Knowledge of ICH/GCP Guidelines
- Knowledge of SAE reporting requirements
- Experience using data review tools is preferred
- Quality focus, analytical skills, and ability to concisely summarize large amounts of complex information
- Proven ability to prioritize and manage multiple tasks with conflicting deadlines
- Excellent time management
- Very good interpersonal and communication skills
- Team player, able to work individually
- Ability and willingness to work cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas