Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Safety

Job Opportunity At AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

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.

Qualifications:

• MD or equivalent
• Associate Medical Director I Drug safety experience preferred but not required
• Associate Medical Director II - 1 - 2 years drug safety experience with medical assessment/clinical case review required.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.