Overview

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In this role you drive quality and consistency in clinical safety data review, supporting medical accuracy and timely case closure. You’ll collaborate with study physicians and cross-functional teams to facilitate safety data review, reporting, and study-start activities. The position emphasizes data-driven medical evaluation, quality of deliverables, and process improvement within a global pharmacovigilance context.

Responsabilidades

- Ensure consistent processes and efficient review of critical clinical/safety data
- Review patient-level clinical/safety data for medical accuracy, coding consistency, and queries for accurate assessment and case closure
- Prepare aggregated data visualizations and facilitate study-level safety data meetings
- Contribute to study start-up activities (documents, tools setup)
- Serve as a member of the Extended Study Team and report on TRISARC deliverables
- Collaborate with study physicians/clinical scientists for standardized high-level data review and medical evaluation
- Escalate urgent/critical medical cases to the study physician/medical scientist as appropriate
- Provide input into automated patient narratives and handwritten narratives process




- Lead the quality of own deliverables
- Perform tasks assigned by Directors, Associate Directors Clinical Trial Safety
- Provide input into non-drug project work including training, continuous improvement, and procedures development

Requisitos principales

- Educational degree (BSc/MSc/PhD) in Life Science or equivalent
- 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 xugodme 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 to work cross-functionally with internal and external partners on integral studies across phases/therapy areas

- interpersonal skills
- communication
- team collaboration
- Pharmacovigilance / drug safety
- ICH/GCP guidelines
- SAE reporting

Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.

📌 Clinical Trial Safety Scientist (FSP - Permanent Home Based) - barcelona
🏢 Jobrapido
📍 Barcelona