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Clinical Safety ScientistThe 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. The CSS assists the protocol lead in safety reporting activities for multiple clinical trials and may collaborate with cross‑functional colleagues within clinical development, clinical operations, case processing, and medical safety review.Key ResponsibilitiesIntake of reportable safety event information from clinical trial investigator sitesReview, manage and create individual case safety reports for each eventEnsure 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 timeframesCollaborate with cross‑functional colleagues as neededComplete protocol‑specific activities as requiredActively participate and ensure effective communication with the protocol lead and other team members supporting their protocolsAppropriately elevate protocol or individual event issues with other stakeholders, including CRAs/CRMs or protocol leadsQualifications & SkillsBasic 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 elevate problems and contribute to issue resolutionTime management and organizational skillsStrong communication skills with advanced oral and written English skillsAdvanced computer, database skillsIndependent, strong analytical, and problem‑solving skillsAbility to work under pressure, with a strong sense of responsibility and accountabilityEducation RequirementM.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. Equivalent M.D./D.O. or other medical degree also acceptable.Work ExperienceMinimum 1 year of experience in a patient care setting, or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.#J-18808-Ljbffr
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