BioSpace, Inc.
Associate Medical Director/Medical Director, Medical Safety Evaluation, Translat
BioSpace, Inc., North Chicago, Illinois, us, 60086
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:
Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance, supporting all patient safety activities.
Responsibilities:
Understands and applies pharmacology, chemistry, and non-clinical toxicology to effectively conduct safety surveillance
Conducts safety surveillance for pharmaceutical/biological/drugdevice combined products; contributes to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, and risk management plans
Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyzes and interprets aggregate safety data and communicates these analyses and interpretations to cross-functional teams
Effectively writes, reviews, and provides input on technical documents
Leads the strategy for periodic reports (DSURs, PSURs, PADERs, etc.)
Oversees safety surveillance and pharmacovigilance activities for products in clinical trials
Leads and implements risk management strategy for assigned products
Key Stakeholders: Group Medical Director, Executive Director, TA Head, PST Lead, Analytics/Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine
Qualifications
MD/DO with 2+ years of residency with patient management experience
24 years of pharmacovigilance experience in the pharmaceutical industry
Effectively analyzes and guides analysis of clinical data and epidemiological information required
Effectively writes technical documents with direction
Ability to effectively present recommendations/opinions in a group environment
Fluency, both written and oral, in English
Self-starting and can work independently
Works collaboratively and leads cross-functional teams
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:
Supporting the Product Safety Leads (PSTLs) and potentially leading one or more products as the PSTL under the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and assessment. Interpreting regulations related to pharmacovigilance, supporting all patient safety activities.
Responsibilities:
Understands and applies pharmacology, chemistry, and non-clinical toxicology to effectively conduct safety surveillance
Conducts safety surveillance for pharmaceutical/biological/drugdevice combined products; contributes to the authorship of key pharmacovigilance documents, including but not limited to medical safety assessments, regulatory responses, and risk management plans
Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyzes and interprets aggregate safety data and communicates these analyses and interpretations to cross-functional teams
Effectively writes, reviews, and provides input on technical documents
Leads the strategy for periodic reports (DSURs, PSURs, PADERs, etc.)
Oversees safety surveillance and pharmacovigilance activities for products in clinical trials
Leads and implements risk management strategy for assigned products
Key Stakeholders: Group Medical Director, Executive Director, TA Head, PST Lead, Analytics/Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine
Qualifications
MD/DO with 2+ years of residency with patient management experience
24 years of pharmacovigilance experience in the pharmaceutical industry
Effectively analyzes and guides analysis of clinical data and epidemiological information required
Effectively writes technical documents with direction
Ability to effectively present recommendations/opinions in a group environment
Fluency, both written and oral, in English
Self-starting and can work independently
Works collaboratively and leads cross-functional teams
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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