Purpose:

The primary focus of this position is the medical review of clinical trial SAEs including causality assessment and company analysis development combined with therapeutic area leadership.

Responsibilities:

• Contributes above the level of individual case review through leadership of individual project or initiative.
• Provides overall leadership to one therapeutic area in primary role; may also serve in secondary role for additional therapeutic area.
• May have people management responsibilities with one or more direct reports.
• Performs medical review of clinical SAEs.
• Develops Company Analysis for SUSARs.
• Responsible for accurate and timely communication with all clinical trial stakeholders.
• Performs causality assessment of adverse events in post-marketing individual case safety reports.
• Understands safety profile of assigned AbbVie products and development compounds as well as safety aspects of relevant therapeutic area drugs and patient populations. ‘
• Understands disease state for each indication within assigned AbbVie products and development compounds.
• Understands global regulations, processes and practices.
• Contributes as requested to PPS initiatives, controlled procedures and MSO training activities; supports audits, inspections and CAPA investigations as necessary