Organization: Global Patient Safety

Team: PV Operations

Group Purpose: To provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.

Job Summary:

•To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)

•Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.

•To act as a point of contact for Case Management on medical content of ICSRs

Key Activites:

• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
• Execute ICSR case escalation as appropriate
• Execute appropriate case follow up per SOPs

• Support medical coding conventions,...