Full Job Description
Purpose:
The primary focus of this position is the Medical Safety Review (MSR) 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 MSR training activities; supports audits, inspections and CAPA investigations as necessary.
Qualifications
o MD or equivalent
o Associate Medical Director I - Drug safety experience preferred but not required
o Associate Medical Director II - 1 - 2 years drug safety experience with medical assessment/clinical case review required.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• 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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
