Postúlate en Kit Empleo: kitempleo.com.co/empleo/1b1ohs

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.
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 protocols.
Appropriately escalated protocol or individual event issues with stakeholders including CRAs/CRMs.
Required Skills
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
Requisition ID: R******
#J-*****-Ljbffr

Postúlate en Kit Empleo: kitempleo.com.co/empleo/1b1ohs

📌 Scientist, Drug Safety (Bogotá)
🏢 MSD LATAM
📍 Bogotá