Allergan Product Surveillance Representative I in Austin, Texas
Product Surveillance Representative I
Austin, Texas, United States at https://agn.referrals.selectminds.com/jobs/6167/other-jobs-matching/location-only
Aug 01, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Under general direction, the Product Surveillance Representative will field incoming phone calls from patients, health care professionals, and internal personnel reporting adverse events or calling with questions regarding complaint investigations and product claims. The Product Surveillance Representative will provide information, initiate complaint files, and process claims for financial reimbursement and replacement products in accordance with Allergan’s internal policies and applicable regulatory requirements.
“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. ”
- Initiate and conduct initial investigation for complaint files, following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information reported in order to conduct immediate follow up with complainant to obtain required information.
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 information across all product lines for complaint data. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across all product lines are handled appropriately.
Receive information and respond to questions for on-going complaint investigations and update applicable records.
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.
- 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.
- 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.
- Support the department on special projects as needed.
Essential Skills and Abilities
Ability to read, analyze, and interpret 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, FDA’s Quality System Regulation 21 CFR Part 820, FDA MDR regulation 21 CFR Part 803, International standard ISO 13485:2003, and the Canadian Medical Devices Regulations; 1998.
Knowledge of current MDR regulations, guidelines, and interpretations.
Knowledge of clinical, surgical techniques and procedures, and medical terminology.
Skill in demonstrating a professional phone manner.
Effective communication with physicians and nurses as required.
Expertise in complaint policies and requirements.
Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
Ability to learn about Allergan Medical’s products and procedures/techniques associated with their use.
Ability to take initiative and make decisions.
Ability to accurately perform detail-oriented work.
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 think critically and analytically to evaluate each record on a case-by-case basis.
AA degree, with two to three years previous experience in customer service or clinical setting; or equivalent combination of education and experience. Bachelor’s degree is preferred.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.