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Product Surveillance Tech
Under general direction, the Product Surveillance Representative III will investigate and maintain complaint files, in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the FDA and international Competent Authorities.
In addition will process claims for financial reimbursement and replacement products in accordance with Allergan’s reimbursement policy. Act as a key resource within the department by mentoring Representatives, monitoring complaints and call queues, and providing ongoing coaching and training. The Product Surveillance Representative III is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Provides technical and administrative support to internal and external customers.
KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:
1. Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make follow calls to reporters.
• Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files. Code complaint information according to Post Market Spreadsheet Report (PSR), Retrieval Program.
• Assess incoming documentation, including clinical forms and medical information, 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. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across product lines are handled appropriately.
• 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).
• Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure compliance and customer service.
• Assist in resolving issues by responding to inquiries and answering technical questions
Education and Experience:
Bachelor’s degree with one to two years previous experience in customer service or clinical setting or equivalent combination of education and experience.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)?
• Customer service experience
• Familiarity with Regulation pertaining to devices/510K (i.e. FDA, MHRA, etc.)
* Flexibility in managing multiple tasks and expectations.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.