Associate Medical Director (PS-MD)
About 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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.
- 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 Global Patient Safety (GPS) initiatives, controlled procedures and MSR training activities; supports audits, inspections and CAPA investigations as necessary.
Qualifications
MD or equivalent1 - 2 years drug safety experience with medical assessment/clinical case review required
Benefits
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.