Complaint Analyst II
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Title : Product Complaint Analyst II
Purpose : Individual will work in AbbVie’s 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. Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
- 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 problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
- 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.
- Creates and reviews documentation to assure it meets GMP standards and can be used for regulatory filings and/or reporting. Examples include: Medical Device Reports and Ministry of Health inquiries.
- Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
- Serve as main resource for the team or a subject matter expert on complaint handling.
- 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 Degree required or 3-5 years of relevant work experience. Preferred degree in nursing, pharmacy, medical technology, engineering or scientific background(MLT, LPN, RN).
- 2+ years’ work experience in a cGMP related industry or in a clinical setting is preferred
- Expertise in complaint handling and process.
Significant Work Activities
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.