Clinical Trial Safety Scientist (Home Based)

About the role

iQVIA is looking for a Clinical Trial Safety Scientist to work permanently and from home. The role reviews patient-level clinical and safety data, supports study start-up and contributes to safety-related deliverables within the Extended Study Team.

Key responsibilities

• Ensure consistent processes and efficient review of critical clinical and safety data
• Review patient-level clinical and safety data on an ongoing basis, check medical accuracy and completeness, coding consistency and raise queries where needed
• Prepare aggregated data visualisations and facilitate meetings on safety data review at study level
• Contribute to study start-up activities such as input to documents and setup of tools
• Serve as a member of the Extended Study Team and report on TRISARC deliverables
• Work with study physicians and clinical/project scientists on high-level data review and medical evaluation
• Escalate urgent and critical medical cases to the study physician or medical scientist
• Provide input on automated and handwritten patient narratives, including guidelines and quality control
• Lead quality of own deliverables and take on tasks assigned by the Directors and Associate Directors Clinical Trial Safety
• Contribute to non-drug projects such as training, continuous improvement and procedure development

Required profile

• Degree (BSc/MSc/PhD) in Life Sciences or equivalent experience in directly related fields
• Minimum 2 years of experience in pharmacovigilance or drug safety
• Understanding of the clinical study and drug development process
• Knowledge of ICH/GCP guidelines and SAE reporting requirements
• Proven ability to prioritise and manage multiple tasks with conflicting deadlines, with excellent time management
• Very good interpersonal and communication skills, team player who can also work independently
• Willingness to work cross-functionally with internal and external partners on global studies

Required skills

• Quality focus and analytical skills, able to summarise large amounts of complex information
• Experience using data review tools is preferred