Medical Director, Medical Safety Review

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.

Purpose:

The primary focus of this role is to provide Medical Safety Review (MSR) departmental and therapeutic area leadership in addition to medical review of clinical trial SAEs and associated functional area activities. 

Responsibilities: 

• Demonstrates significant functional area ownership; contributes above and beyond the level of individual case review by leading multiple projects or initiatives (including complex, high risk activities)
• Partners to develop MSO departmental strategy.
• Provides overall leadership to one or more therapeutic areas in primary role; may also serve in secondary role for additional therapeutic areas.
• Responsible for people management with one or more direct reports.
• Performs medical review of clinical SAEs.
• Develops Company Analysis for SUSARs as required. 
• 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 and can operationalize changes as necessary.
• Leads PPS initiatives, changes to controlled procedures and MSR training activities; supports audits, inspections and CAPA investigations as necessary.

• MD / DO with 2+ years of residency with patient management experience required
• Master Public Health is preferred in addition to MD / DO
• Effectively analyze clinical data and epidemiological information required
• Effectively write technical documents with direction
• Work collaboratively in a team environment and be self-starting and able to work independently
• Ability to effectively present recommendations / opinions in group environment
• Fluency, both written and oral, in English

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 postingbased 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 orless 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 short-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 paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

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. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html