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Job description
Company Description
About AbbVie
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 and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). 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 combined products
Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
Effectively write, review and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (PSUR’s, PADER’s etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.
Qualifications
MD / DO with 2+ years of residency with patient management experience
Master Public Health is preferred in addition to MD / DO, not required
8 - 10 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
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. 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 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 employer 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Worksite address
irvine, CA, 92713, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.