Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Safety

Role Summary

Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Safety. Primary focus on 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.

Qualifications

• MD or equivalent
• Associate Medical Director I ‚Äì Drug safety experience preferred but not required
• Associate Medical Director II - 1‚Äì2 years drug safety experience with medical assessment/clinical case review required