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    Specialist, Reporting I - Branchburg, United States - AbbVie, Inc

    AbbVie, Inc
    AbbVie, Inc Branchburg, United States

    3 weeks ago

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    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 - 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

    The Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders.

    The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints.

    They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

    Responsibilities


    • Decision maker for reportability decisions
    • Lead for all vigilance reporting, including local and global submissions
    • Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate
    • Ensures that relevant stakeholders have visibility to the reporting and where they are in the process
    • Manages regular reporting needs and external requests (i.e. from the FDA)
    • Manage the timeline for end to end reporting
    • Owns translation services for reporting
    Qualifications

    Qualifications


    • Bachelor's Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background
    • 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred)
    • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
    • Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
    • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
    • Solid written/verbal communication and organizational skills.
    • Knowledge and application of computer systems for word processing and complaint management.
    • Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
    Additional Information

    Applicable only to applicants
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