Job Description Clinical Safety Scientist The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review. Key Responsibilities: Intake of reportable safety event information from clinical trial investigator sitesReview, manage and create individual case safety reports for each eventEnsure that all information required for a clinically complete and accurate case is presentGenerate safety queries to the trial investigator sites to ensure case report accuracy and completenessPrioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframesMay collaborate with cross-functional colleagues as neededQualifications & Skills Basic understanding of scientific and medical conceptsBasic understanding of drug developmentBasic knowledge of GCP and ICH regulationsAbility to work as part of a cross-functional teamAbility to identify and escalate problems and contribute to issue resolutionTime management and organizational skillsStrong communication skills with advanced oral and written English skillsAdvanced computer, database skillsEducation Requirement: M.D. with minimum 1 year of clinical work experience in a patient care setting or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.Preferred: Experience in patient care setting, drug safety and pharmaceutical drug developmentCurrent Employees apply HERE Current Contingent Workers apply HERE Employee Status: Project Temps (Fixed Term) Flexible Work Arrangements: Hybrid Job Posting End Date: 04/24/2025 Requisition ID: R344972 #J-18808-Ljbffr