Serious and unexpected suspected adverse reaction (susar) reporting
Global medical safety operations (gmso)
Directly leading the daily operational activities of a Global Case Processing team within Global Medical Safety Operations, ensuring effective workload management and adherence to ICSR quality and timeline standards
Job Summary
Directly leading the daily operational activities of a Global Case Processing team within Global Medical Safety Operations, ensuring effective workload management and adherence to ICSR quality and timeline standards.
Managing and supporting team members in day‑to‑day case processing activities through coaching, guidance, performance management, and ongoing staff development.
Ensuring the quality, accuracy, and regulatory compliance of team‑processed ICSRs, with particular focus on SUSAR reporting requirements, including completeness of case narratives, coding activities, AOSE, and related documentation.
Matching Summary
Directly leading the daily operational activities of a Global Case Processing team within Global Medical Safety Operations, ensuring effective workload management and adherence to ICSR quality and timeline standards.
Skills & Requirements
Must-have
Drug Safety Associates (DSAs)
Serious and Unexpected Suspected Adverse Reaction (SUSAR) reporting
Global Medical Safety Operations (GMSO)
Quality, accuracy, and regulatory compliance
Pharmacovigilance regulations
Nice-to-have
Inclusive work environment
Patient insights fuel science-based advancements
Developments in treatments and cures
Key Requirements
Bachelor’s degree in a health‑related or scientific discipline
Minimum of 5 years of pharmaceutical industry or clinical experience
Demonstrated knowledge of global safety reporting regulations