Clinical Safety Scientist – Clinical Trials Safety Reporting

About the role

The Clinical Safety Scientist (CSS) supports safety reporting for multiple clinical trials across therapeutic areas, contributing to investigational product development from early to late stages. Working closely with protocol leads and cross‑functional teams, the CSS ensures accurate and timely case safety reporting.

Key responsibilities

• Intake and review of reportable safety events from investigator sites.
• Create and manage individual case safety reports, ensuring clinical completeness.
• Generate safety queries to investigators to verify data accuracy.
• Prioritize daily work to meet database entry timelines.
• Collaborate with clinical development, operations, case processing, and medical safety review teams.
• Support protocol‑specific activities and maintain effective communication with protocol leads.
• Escalate protocol or event issues to CRAs, CRMs, or protocol leads as needed.

Required profile

• MD or DO (or equivalent medical degree) with at least 1 year of patient‑care experience or 2 years in pharmaceutical/drug development or safety.
• Basic understanding of scientific, medical, and drug‑development concepts.
• Knowledge of GCP and ICH regulations.
• Strong analytical, problem‑solving, and time‑management skills.
• Advanced oral and written English communication.

Required skills

• Adverse Event Reporting
• Clinical Development
• Clinical Reporting
• Clinical Trial Management
• Clinical Trials Monitoring
• Cross‑Functional Collaboration
• Data Integrity
• Data Management
• Drug Development
• Drug Safety Surveillance
• Good Clinical Practice (GCP)
• Regulatory Communications
• Regulatory Compliance Audits
• Regulatory Interpretation
• Regulatory Reporting
• Training and Development