Analyst, Complaint Processing I

Purpose:
Individual will work in AbbVies global quality organization processing pharmaceutical medical device and combination product complaints and inquiries. Interface with internal and external AbbVie 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 AbbVie 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 AbbVie 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.

Qualifications :

• 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 Bachelors 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

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time