Reporting Specialist II

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Are you looking for an exciting opportunity where you can utilize your expertise as a Reporting Specialist? Look no further! We are currently seeking a talented individual to join our Tissue team as a Reporting Specialist II. In this role, you will have the chance to work alongside internal and external stakeholders, ensuring the accurate and timely reporting of complaints. You will collaborate with various teams, including pharmacovigilance and device quality assurance, to guarantee compliance with regulations. As a subject matter expert, you will also have the opportunity to manage more complex reporting needs and provide mentorship to junior team members. If you are seeking a challenging position where you can make a significant impact, this role is perfect for you. Apply now and join our team of dedicated professionals!

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 and effectively communicate throughout


• Manages more complex reporting needs and external requests (i.e. from the FDA)


• Manage the timeline for end to end reporting


• Owns translation services for reporting


• Seeks efficiencies and ways to continuously improve our existing processes


• Provide mentorship to Reporting Specialist I team members



 
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Significant Work Activities -Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

• Bachelor’s Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background


• 7+ 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.


• In-depth 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.



 
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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 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.