Clinical Trial Safety Scientist – FSP

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🔥 1 minute ago

🇪🇸 Spain – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Clinical Scientist

👻 Ghost score 10%

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Logo of IQVIA

IQVIA

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Ensure consistent processes and efficient review of critical clinical/safety data • Review patient-level clinical/safety data for medical accuracy, completeness, coding consistency, and case closure • Prepare aggregated data visualizations and facilitate study-level safety data review meetings • Contribute to study start-up activities, including applicable documents and tool setup • Serve as a member of the Extended Study Team and report on TRISARC deliverables • Support standardized high-level data review and medical evaluation with study physicians and/or clinical/project scientists • Escalate urgent and critical medical cases to the study physician/medical scientist • Provide input into automated and handwritten patient narrative processes, including guidelines and quality control • Lead the quality of own deliverables • Perform tasks assigned by Directors and Associate Directors of Clinical Trial Safety • Contribute to non-drug project work, training, continuous improvement, and procedure development

🎯 Requirements

• Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields • Minimum 2+ 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 with internal and external partners on global studies, across different phases of drug development or different therapy areas

🏖️ Benefits

• Permanent home-based work arrangement

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