• Serve as the safety physician lead for designated Dianthus’s product. • Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment, ensuring appropriate coding and compliance with global regulations. • Perform aggregate data analysis and interpretation. • Author and provide medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.) or other deliverables as appropriate. • Contribute to / lead safety review committee activities, including individual and aggregate data analyses, signal detection and evaluation, interpretation of safety signals and trends, and documentation and communication of safety assessments. • Contribute to relevant clinical and regulatory documents, such as study protocols, investigator brochures, statistical analysis plan, and clinical study reports. • Collaborate with relevant functions such as clinical development, data management, regulatory affairs, biostatistics, and medical affairs on relevant safety issues. • Review and summarize relevant scientific and clinical literature to support safety evaluations and regulatory submissions • Support the senior medical director / designee on complex pharmacovigilance tasks/activities such as integrated safety analyses, benefit–risk assessments, and development of risk management strategies. • Support internal and external pharmacovigilance audits and regulatory inspections. • Stay current with global pharmacovigilance regulations, guidelines, and best practices.