Purpose:

Individual will work in Abb Vie’s global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal and external Abb Vie customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding Abb Vie product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.

• Assure complaint records meet global requirements.

• Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related event.

• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.

• Identification of potentially reportable events and notification to appropriate functional groups and management.

• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, Abb Vie functional areas and regulatory agencies.

• Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.

• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

• Knowledge of FDA requirements for 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.

• A Bachelor's Degree required or 1-2 years of relevant work experience. Preferred degree in technology or scientific background (MLT, LPN, RN).

• 0-2 years’ work experience in a cGMP related industry or in a clinical setting is preferred

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. ​

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Abb Vie 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.