Clinical Trial Safety Scientist

• 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, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas

Education/Experience

• Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields

Responsibilities

• Ensure consistent processes and efficient review of critical clinical/safety data
• Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
• Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level
• Contribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents, tools set up)
• Serve as a member of the Extended Study Team and report on TRISARC deliverables
• Work with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation
• Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate
• Provide input into the process of setting automated patient narratives, if applicable
• Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable
• Lead quality of own deliverables
• Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety
• Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed