Clinical Trial Safety Scientist – FSP

This is a fully remote position, open to applicants in Spain.

📋 Description

• Ensure the implementation of consistent processes and the efficient assessment of critical clinical and safety data.

• Evaluate patient-level clinical and safety data for medical accuracy, completeness, coding consistency, and case closure.

• Create aggregated data visualizations and facilitate meetings for study-level safety data review.

• Participate in study start-up activities, including the preparation of relevant documents and tool configurations.

• Act as a member of the Extended Study Team and report on TRISARC deliverables.

• Assist in standardized high-level data reviews and medical evaluations alongside study physicians and/or clinical/project scientists.

• Raise urgent and critical medical cases to the attention of the study physician or medical scientist.

• Provide insights into both automated and handwritten patient narrative processes, including guidelines and quality control measures.

• Take the lead on ensuring the quality of personal deliverables.

• Complete tasks assigned by Directors and Associate Directors of Clinical Trial Safety.

• Engage in non-drug project initiatives, training, continuous improvement, and the development of procedures.

⛳️ Requirements

• A degree in Life Science (BSc/MSc/PhD) or equivalent professional experience in related fields.

• At least 2 years of experience in Pharmacovigilance or Drug Safety.

• Familiarity with the clinical study and drug development processes.

• Knowledge of ICH/GCP Guidelines.

• Understanding of SAE reporting requirements.

• Experience with data review tools is preferred.

• A quality-focused mindset, strong analytical skills, and the ability to summarize complex information succinctly.

• Demonstrated capability to prioritize and manage multiple tasks with competing deadlines.

• Excellent time management abilities.

• Strong interpersonal and communication skills.

• A team player who can also work independently.

• Willingness and ability to collaborate cross-functionally with internal and external partners on global studies across various phases of drug development and different therapeutic areas.

🏝️ Benefits

• Permanent home-based work arrangement.