Aggerate Reporting Specialist

Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contribute to signaling and data mining activities utilizing internal and external sources of data. Perform signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests Develop knowledge of capabilities and limitations of various data sources. Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates utilized by Alnylam. Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues. Proactively disseminates information to safety team members, providing context/urgency as applicable. Communicates clearly to all cross-functional areas including scheduling meetings to provide clarity and resolution of issues. Demonstrates alignment with Alnylam core values. Supports all SRMT preparation and documentation with guidance from mentor and safety physician. Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues. Provide management and training for new staff on department practices and therapeutic area knowledge.

Supervision: Individual is expected to work independently with support from management and colleagues in GPSRM.