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Job 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 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, Xand YouTube.
Job Description
Purpose :
Describes the primary goals, objective or function or outputs of this position. Responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA. Head in ensuring safety in one or more products to through 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
Safety surveillance for pharmaceutical / biological / drug –device combined neuroscience products
Contribute to the authorship of 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
Ability to effectively write, review and provide input on technical documents
Lead the safety strategy for regulatory submissions, including INDs, NDAs, and MAAs and the periodic reports (PSUR’s, PADER’s etc.)
Oversight of safety surveillance and pharmacovigilance activities for neuroscience products in clinical trials and post marketing
Lead and implement risk management strategy for assigned neuroscience products
Qualifications
MD / DO with 2+ years of residency with patient management experience and Master Public
Health is preferred in addition to MD / DO but not required
2 – 4 years of Pharmacovigilance experience in the pharmaceutical industry
Effectively analyze and guide analysis of clinical data and epidemiological information
Effectively present recommendation / opinions in group environment
Write, review and provide input on technical documents
Self-starting and can work independently
Work collaboratively and lead 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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s 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.
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Worksite address
chicago, IL, 60290, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.