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.
*This role could be based in lake county/ San Francisco or could be remote.
Purpose:
To lead Product Safety Teams (PST) 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 (e.g., surveillance, signal detection and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities:
• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combination products.
• Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.
• Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical development and marketed products, applying current regulatory guidance as appropriate.
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross functional teams and regulatory authorities.
• Effectively and independently write, review, and present technical documents.
• Responsible for implementing risk management strategies for assigned products.
• Proactively engaging, inspiring, coaching and mentoring team and colleagues.
• MD / DO with 2+ years of residency with patient management experience.
• Master Public Health is preferred in addition to MD / DO, not required.
• 2-5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
• Effectively analyze and guide analysis of clinical data and epidemiological information.
• Effectively present recommendations / opinions in group environment both internally and externally.
• Write, review and provide input on technical documents.
• Work collaboratively and lead cross-functional teams.
• Ability to lead cross-functional teams in a collaborative environment.
• Fluency, both written and oral, in English.
• Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
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
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Are you ready to make a significant impact in the medical field? Join AbbVie as a Medical Director and help lead our Product Safety Teams in Mettawa, IL! In this pivotal role, you'll ensure that the safety profiles of our innovative products—whether pharmaceutical, biological, or combination products—are meticulously monitored throughout their lifecycle. You'll leverage your expertise in pharmacovigilance, interpreting regulations, and crafting essential safety documentation. Your responsibilities will include overseeing safety surveillance, risk management strategies, and analyzing aggregate safety data, while inspiring and mentoring your team. Your role at AbbVie will shape how we address health challenges across immunology, oncology, neuroscience, and more. If you hold an MD or DO, with at least 2 years of residency experience, and possess 2-5 years of relevant pharmacovigilance experience, you're the kind of candidate we're looking for! Collaborate with cross-functional teams and make independent decisions in a dynamic environment as you guide our commitment to excellence in patient safety. Let's transform lives together at AbbVie, where your contribution can lead to groundbreaking advancements in healthcare!
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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: i...
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