Clinical Trial Safety Scientist (FSP - Permanent Home Based)

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 Education/Experience 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