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Job DescriptionThe Scientist Level Clinical Safety Scientist (CSS) is responsible for supporting safety reporting in clinical trials across multiple therapeutic areas as part of investigational product development programs in early and late-stage development.
The CSS assists the protocol lead in safety reporting activities for multiple clinical trials and supports collaboration 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 sites.Review, manage, and create individual case safety reports for each event.Ensure that all information required for a clinically complete and accurate case is present.Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness.Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes.Collaborate with cross‐functional colleagues as needed.Complete protocol‐specific activities as required.Actively participate and ensure effective communication with the protocol lead and other team members supporting their protocols.Appropriately escalat(e) protocol or individual event issues with other stakeholders,



including CRAs/CRMs or protocol leads.Qualifications & SkillsBasic understanding of scientific and medical concepts.Basic understanding of drug development.Basic knowledge of GCP and ICH regulations.Ability to work as part of a cross‐functional team.Ability to identify and escal(e) problems and contribute to issue resolution.Time management and organizational skills.Strong communication skills with advanced oral and written English skills.Advanced computer, database skills.Independent, strong analytical and problem‐solving skills.Ability to work under pressure, with a strong sense of responsibility and accountability.Education Requirements• 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.
• M.D./D.O. or equivalent degree in Medicine with minimum 1 year of experience in a patient care setting, or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.Required SkillsAdaptabilityAdverse Event ReportClinical DevelopmentClinical MedicineClinical ReportingClinical Trial ManagementClinical Trials MonitoringCross‐Functional CollaborationData IntegrityData ManagementDetail‐OrientedDrug DevelopmentDrug Safety SurveillanceGood Clinical Practice (GCP)Medical Device ManagementPharmaceutical DevelopmentPressure ManagementProduct DevelopmentProtocol DevelopmentRegulatory CommunicationsRegulatory Compliance AuditsRegulatory InterpretationRegulatory ReportingTraining and Development
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Postúlate en Kit Empleo: kitempleo.com.co/empleo/1b1ncj

📌 Scientist, Drug Safety (Fixed Term) (Bogotá)
🏢 Msd Malaysia
📍 Bogotá