Purpose:
The primary focus of this role is to provide Medical Safety Review (MSR) departmental and therapeutic area leadership in addition to medical review of clinical trial SAEs and associated functional area activities.
Responsibilities:
- Demonstrates significant functional area ownership; contributes above and beyond the level of individual case review by leading multiple projects or initiatives (including complex, high risk activities)
- Partners to develop MSO departmental strategy.
- Provides overall leadership to one or more therapeutic areas in primary role; may also serve in secondary role for additional therapeutic areas.
- Responsible for people management with one or more direct reports.
- Performs medical review of clinical SAEs.
- Develops Company Analysis for SUSARs as required.
- 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 and can operationalize changes as necessary.
- Leads PPS initiatives, changes to controlled procedures and MSR training activities; supports audits, inspections and CAPA investigations as necessary.
