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Clinical Safety Scientist

hace 2 semanas

Bogota, Colombia MSD A tiempo completo

The 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. Key responsibilities: - Intake 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 - Reconcile critical data points between clinical and safety database - Collaborate closely with cross functional colleagues Required qualifications, skills & experience: - Strong understanding of scientific and medical concepts - Basic understanding of drug development - Experience working as part of a cross-functional team setting - Effective problem-solving skills - Time management/organizational skills - Strong communication skills with advanced oral and written English skills (>90%) - Advanced computer, database skills - Office tools management (Word, Excel, Power point) Education Requirement: - M.D with 1 year of clinical work experience in a patient care setting (different from medical internship) or 2 years relevant pharmaceutical, drug development, and/or drug safety experience Preferred: - Basic knowledge of GCP and ICH regulations - Experience in drug safety - Experience in pharmaceutical drug development **Search Firm Representatives Please Read Carefully** **Employee Status**: Project Temps (Fixed Term) **Relocation**: No relocation **VISA Sponsorship**: **Travel Requirements**: **Flexible Work Arrangements**: **Shift**: **Valid Driving License**: **Hazardous Material(s)**: **Requisition ID**:R164908