BioSpace
Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Saf
BioSpace, South Chicago Heights, Illinois, United States
Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Safety
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Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Safety
role at
BioSpace
Company Description 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. For more information about AbbVie, please visit us at www.abbvie.com.
Purpose 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 Directo r II - 1 - 2 years drug safety experience with medical assessment/clinical case review required.
Compensation and Benefits
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 short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Equal Employment Opportunity 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.
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Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Safety
role at
BioSpace
Company Description 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. For more information about AbbVie, please visit us at www.abbvie.com.
Purpose 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 Directo r II - 1 - 2 years drug safety experience with medical assessment/clinical case review required.
Compensation and Benefits
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 short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Equal Employment Opportunity 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.
#J-18808-Ljbffr