Support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources, ensuring timely and compliant submissions to global regulatory authorities
Job Summary
Support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources, ensuring timely and compliant submissions to global regulatory authorities.
Perform medical coding, narrative writing, listedness assessments, follow-up determination, and Analysis of Similar Events, while ensuring workflow compliance by reviewing safety database timelines and case progression.
Contribute to compliance, productivity, and quality performance metrics, support continuous improvement initiatives and inspection readiness, and make operational decisions aligned with SOPs, work instructions, and regulatory standards.
Matching Summary
Support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources, ensuring timely and compliant submissions to global regulatory authorities.