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 . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
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.
Qualifications
Additional Information
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.
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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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