BioSpace, Inc.
Associate Medical Director, Safety Operations, Pharmacovigilance and Patient Saf
BioSpace, Inc., South Chicago Heights, Illinois, United States
Job Details
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 . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Purpose :
The primaryfocus 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. Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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
Company
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .
Stock Symbol:
ABBV
Stock Exchange:
NYSE
Company info Website http://www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States
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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 . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Purpose :
The primaryfocus 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. Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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
Company
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .
Stock Symbol:
ABBV
Stock Exchange:
NYSE
Company info Website http://www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States
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