Medical Directors
Apply NowCompany: AbbVie
Location: North Chicago, IL 60064
Description:
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 [redacted] on X, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Responsibilities:
1.Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
2.Responsible for safety surveillance for pharmaceutical / biological / drug -device combined early oncology product and implementing risk management strategies for assigned product
3.Lead, set the strategy in collaboration with the development medical lead of study protocols and informed consents. When appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports.
4.Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents. Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
5.Independently write, review, and provide input on technical documents. Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSUR's, PADER's and Safety sections of the IBs)
6.Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
Qualifications
1.MD / DO with 2+ years of residency with patient management experience
2.5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
3.Effectively analyze and guide analysis of clinical data and epidemiological information
4.Effectively present recommendations / opinions in group environment both internally and externally
5.Write, review and provide input on technical documents
6.Work collaboratively and lead cross-functional teams
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. To learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html (US & Puerto Rico only)
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 [redacted] on X, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Responsibilities:
1.Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
2.Responsible for safety surveillance for pharmaceutical / biological / drug -device combined early oncology product and implementing risk management strategies for assigned product
3.Lead, set the strategy in collaboration with the development medical lead of study protocols and informed consents. When appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports.
4.Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents. Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
5.Independently write, review, and provide input on technical documents. Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSUR's, PADER's and Safety sections of the IBs)
6.Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
Qualifications
1.MD / DO with 2+ years of residency with patient management experience
2.5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
3.Effectively analyze and guide analysis of clinical data and epidemiological information
4.Effectively present recommendations / opinions in group environment both internally and externally
5.Write, review and provide input on technical documents
6.Work collaboratively and lead cross-functional teams
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. To learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html (US & Puerto Rico only)