Medical Director, Medical Safety Review

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Qualifications :

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

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 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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paidand may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

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; contri...

Purpose:

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.

Qualifications :

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

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 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.

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

Work :

Employment Type :

Full-time

Key Skills

EMR Systems
Post Residency Experience
Occupational Health Experience
Clinical Research
Managed Care
Primary Care Experience
Medical Management
Utilization Management
Clinical Development
Clinical Trials
Leadership Experience
Medicare

Apply Now

About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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