Purpose: Under general direction, the Product Surveillance Representative I will perform a variety of complex duties associated with supporting current and potential patients of various Post Market Clinical Studies and Commercial Products. The Commercial Product Surveillance Representative will investigate and maintain complaint files and determine reportability in compliance with regulations established by the FDA and international regulatory bodies.
The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971.
- Investigate and maintain complaint files, following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make decisions for reportability under MDR regulation, 21 CFR 803 and international regulations.
- Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files.
- Assess incoming documentation for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Interface with device analysis lab regarding analysis results and processing complaints.
- Review adverse events reported in clinical studies to determine if events meet the regulatory definition of potentially reportable event or complaint.
- Initiate Further Investigation, and any additional follow-up and communication pertinent to the MDR as needed. Track files sent to Quality Assurance for Further Investigation and complete necessary documentation. Evaluate Further Investigation results, summarize findings, and determine and document the conclusion(s).
- Communicate with the Quality Assurance, Clinical Studies, Customer Care, Operations, Marketing departments, and Allergan manufacturing facilities.
AA degree; Bachelor’s degree is preferred.
2-3 years previous experience in customer service or clinical setting; or equivalent combination of education and experience.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents.
Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
Ability to handle confidential data in accordance with HIPAA and related international standards.
Ability to function in a controlled environment regulated by the FDA and other regulatory authorities. The specific requirements include, but may not be limited to: Knowledge of current MDR regulations, guidelines, and interpretations.
Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures).
Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
Significant Work Activities: N/A
Job Type: Experienced