Medical Director, Medical Safety Review

Responsibilities:
- Provide Medical Safety Review (MSR) departmental and therapeutic area leadership, including medical review of clinical trial SAEs.
- Demonstrate functional area ownership by leading multiple projects/initiatives, including complex/high-risk activities.
- Partner to develop MSO departmental strategy.
- Provide leadership to one or more therapeutic areas (primary) and possibly additional therapeutic areas (secondary).
- Manage people with one or more direct reports.
- Perform medical review of clinical SAEs.
- Develop Company Analysis for SUSARs as required.
- Ensure accurate and timely communication with clinical trial stakeholders.
- Perform causality assessment for adverse events in post-marketing individual case safety reports.
- Understand safety profiles of assigned AbbVie products/development compounds and relevant therapeutic area drugs/patient populations.
- Understand disease state for each indication.
- Understand global regulations/processes and operationalize changes.
- Lead PPS initiatives, controlled procedure changes, and MSR training; support audits/inspections/CAPA investigations as necessary.

Qualifications:
- MD/DO with 2+ years of residency and patient management experience (required).
- Master Public Health (preferred).
- Ability to analyze clinical/epidemiological data; write technical documents; collaborate and work independently.
- Ability to present recommendations/opinions in a group environment.
- Fluency in English (written and oral).

Benefits (if eligible/explicitly stated):
- Paid time off; medical/dental/vision insurance; 401(k); short-term incentive programs.