Clinical Trial Safety Scientist (Permanent Home Based)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

• Educational degree (BSc/MSc/PhD) in Life Science or equivalent work experience
• Minimum 4+ years of experience in Pharmacovigilance / Drug Safety
• Understanding of clinical study and drug development processes
• Knowledge of ICH/GCP Guidelines
• Knowledge of SAE reporting requirements
• Experience using data review tools is preferred
• Quality focus and analytical skills
• Ability to concisely summarize complex information
• Proven ability to prioritize and manage multiple tasks with conflicting deadlines
• Excellent time management
• Very good interpersonal and communication skills
• Team player with ability to work individually
• Ability and willingness to work cross-functionally on global studies across different phases and therapy areas

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

IQVIA maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions during recruitment will result in disqualification or termination in accordance with applicable law.