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 l
📌 Sr. Scientist, Drug Safety (Bogotá)
🏢 Msd
📍 Bogotá
Postulate a este anuncio
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.