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Job Description

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. 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 sites.
Review and manage 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.

May collaborate with cross-functional colleagues as needed.




Complete protocol specific activities as required
Actively participate and ensure effective communication with protocol lead and other team

members supporting their protocols

Appropriately escalate protocol or individual event issues with other stakeholders including

CRAs/CRMs

Required Skills

Adaptability, Adaptability, Adverse Event Report, CiviCRM, Clinical Development, Clinical Medicine, Clinical Physiology, Clinical Reporting, Clinical Risk Management, Clinical Sciences, Clinical Trial Management, Clinical Trials Monitoring, Cross-Functional Collaboration, Data Integrity, Data Management, Detail-Oriented, Drug Safety Surveillance, Good Clinical Practice (GCP), Medical Device Management, Pharmacokinetics, Product Development, Protocol Development, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation {+ 2 more}

Preferred Skills

Current Employees apply HERE

Current Contingent Worker

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📌 Scientist, Drug Safety (Bogotá)
🏢 Sin nombre
📍 Bogotá