Job Description
The Senior Scientist, Clinical Safety Scientist (CSS) supports safety reporting for clinical trials across multiple therapeutic areas and investigational product development programs, from early- through late-stage development. This includes in-house trials and may include support for outsourced trials from integrations. The CSS collaborates with cross-functional colleagues in clinical development, clinical operations, case processing, and medical safety review.
Key Responsibilities:
Intake, review and management of individual reportable safety events from clinical trial investigator sites.
Ensure that all information required for a clinically complete and accurate case is present.
Develop clinically focused safety queries for trial investigator sites to support accurate and complete case reports.
Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes.
Complete protocol specific activities as required.
Maintain Protocol Specific Training (PST) requirements for assigned trials,



including new amendments, to ensure protocol knowledge and understanding of their impact on safety reporting.
Actively participate and ensure effective communication with other team members supporting their protocols.
Appropriately escalate protocol or individual event issues with other stakeholders including CRAs/CRMs/CS/CD
May lead one or more protocols (as a protocol lead)
Triage safety queries from the clinical team and medical safety review team (ICMR-MSR) as applicable.
As a protocol lead participate as a core member of the Medical Monitoring Team
As a protocol lead participate and collaborate with the Clinical Trial Team
As a protocol lead reconcile critical data points between clinical and safety database as required.
Collaborate closely with cross functional colleagues.
Collaborate with external colleagues and business partners.
May serve as an expert resource for less experienced colleagues.
May pr

📌 Sr. Scientist, Drug Safety (Bogotá)
🏢 Msd
📍 Bogotá