BioSpace
Medical Director, Oncology & Specialty Patient Safety
BioSpace, North Chicago, Illinois, us, 60086
Medical Director, Oncology & Specialty Patient Safety
Join us to apply for the
Medical Director, Oncology & Specialty Patient Safety
role at
AbbVie .
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 including immunology, oncology, neuroscience, and eye care.
Purpose To lead Product Safety Teams and support one or more products as the PST lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle. Interpret regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities
Understand and apply pharmacology, chemistry, and non‑clinical toxicology to conduct safety surveillance.
Conduct safety surveillance for pharmaceutical, biological, or drug‑device combination products.
Lead, oversee, and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, risk management plans, and periodic safety reports (DSURs, PBRERs/PSURs, PADERs).
Lead safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance.
Analyze and interpret aggregate safety data and communicate findings to cross‑functional teams and regulatory authorities.
Write, review, and present technical documents.
Implement risk management strategies for assigned products.
Engage, inspire, coach, and mentor team members and colleagues.
Qualifications
MD / DO with 2+ years of residency and patient management experience.
Master of Public Health preferred but not required.
2–5 years of pharmacovigilance or clinical development experience in the pharmaceutical industry.
Ability to analyze and guide analysis of clinical data and epidemiological information.
Effective communication of recommendations in group settings internally and externally.
Proficiency in writing, reviewing, and providing input on technical documents.
Collaboration and leadership of cross‑functional teams.
Fluency in English, written and oral.
Independent decision‑making and ability to manage uncertainty and complexity.
Additional Information
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.
We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and a 401(k) plan.
Eligibility to participate in short‑term and long‑term incentive programs.
Equal Opportunity Employer 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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Medical Director, Oncology & Specialty Patient Safety
role at
AbbVie .
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 including immunology, oncology, neuroscience, and eye care.
Purpose To lead Product Safety Teams and support one or more products as the PST lead, ensuring that the safety profile of one or more products is adequately monitored and characterized throughout the product lifecycle. Interpret regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities
Understand and apply pharmacology, chemistry, and non‑clinical toxicology to conduct safety surveillance.
Conduct safety surveillance for pharmaceutical, biological, or drug‑device combination products.
Lead, oversee, and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, risk management plans, and periodic safety reports (DSURs, PBRERs/PSURs, PADERs).
Lead safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance.
Analyze and interpret aggregate safety data and communicate findings to cross‑functional teams and regulatory authorities.
Write, review, and present technical documents.
Implement risk management strategies for assigned products.
Engage, inspire, coach, and mentor team members and colleagues.
Qualifications
MD / DO with 2+ years of residency and patient management experience.
Master of Public Health preferred but not required.
2–5 years of pharmacovigilance or clinical development experience in the pharmaceutical industry.
Ability to analyze and guide analysis of clinical data and epidemiological information.
Effective communication of recommendations in group settings internally and externally.
Proficiency in writing, reviewing, and providing input on technical documents.
Collaboration and leadership of cross‑functional teams.
Fluency in English, written and oral.
Independent decision‑making and ability to manage uncertainty and complexity.
Additional Information
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.
We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and a 401(k) plan.
Eligibility to participate in short‑term and long‑term incentive programs.
Equal Opportunity Employer 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