Product Surveillance Technician III
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.
Under general direction, the Product Surveillance Representative III will investigate and maintain complaint files, determine reportability 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.
“The employee must conduct their work activities in compliance with all Allergan 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. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.”
Supervisory responsibility: (if applicable)
This job has no direct supervisory responsibilities, but the Lead Product Surveillance Representative will be responsible for providing direction and assistance in monitoring the job performance and training of Product Surveillance Representatives.
KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance
1. Initiate, 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. Code complaint information according to Post Market Spreadsheet Report (PSR), Retrieval Program, internal trending, and PMA Annual Updates (where applicable). Make reportability decisions within specified timelines.
• Generate and submit MedWatch, and PSR reports and forms to FDA within specified deadlines.
• 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.
• 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).
- Maintain a knowledge and understanding of current MDR regulations, MDR guidelines, MDR interpretations, product labeling, other federal laws governing medical devices, Department of Transportation (DOT) requirements for explant returns, and the FDA mandated Retrieval Program.
2. Monitor department processes and workflow and provide leadership to team.
- Identify problems and potential issues.
- Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure compliance and customer service.
- Assist in performing monthly audits.
- Analyze work problems and assist Representatives in resolving customer and work related issues.
- Assist in resolving issues by responding to inquiries and answering technical questions regarding Allergan’s product line.
- Monitor incoming queue call flow.
3. Provide generalized company, departmental and product knowledge as required.
• Communicate with the Quality Assurance, Clinical Studies, Customer Care, Operations, Marketing departments, and Allergan manufacturing facilities.
- Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy.
4. Initiate and process product reimbursement and claim records.
- Inform internal and external customers of Allergan’s reimbursement policy and product return requirements.
- Contact internal and external customers if claim is incomplete. Ability to monitor several cases at once, including status and follow-up as necessary.
- Respond to verbal and written requests from internal and external customers for payment of warranty in a timely manner.
- Ability to identify potentially litigious customers, and forward to management for resolution.
5. Provide assistance with various departmental projects that may include:
• Assist in the coordination of department personnel regarding MDR decisions and overall procedures to ensure compliance with MDR regulations.
• Train new staff and conduct training/re-training on company policies, study protocols, MDR regulations, and departmental practices.
• Support the department on special projects as needed.
job QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
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)
- Thorough knowledge in complaint policies and requirements.
- 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.
- Vigilance reporting as prescribed within EEA, EAME, APAC and LATAM regions. Includes Council Directive 93/42/EEC June, 1993 (Medical Device Directive) and other country/regional medical device regulation. Expertise of any transpositions by countries within the EEA.
- 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).
- ISO 13485:2016, ISO 14971, the Canadian Medical Device Regulations 1998, SOR/98-282, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.
- Ability to take initiative and make decisions.
- Ability to demonstrate leadership in job performance by example.
- Ability to maintain confidentiality as it relates to the performance of others and/or on work related issues as advised by Management.
- Ability to learn about Allergan Medical’s products and procedures/techniques associated with their use.
- Ability to accurately perform detail-oriented work.
- Knowledge of clinical, surgical techniques and procedures, and medical terminology.
- Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
- Effective communication with physicians and nurses as required.
- Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
- Ability to handle confidential data in accordance with HIPAA and related international standards.
- Ability to be flexible in changing daily workload priorities as directed.
- Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
- Ability to coordinate and synchronize multiple projects.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
- Skill in demonstrating a professional phone manner.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.