Allergan Product Surveillance Representative II in Austin, Texas
Product Surveillance Representative II
Austin, Texas, United States at https://agn.referrals.selectminds.com/jobs/6244/other-jobs-matching/location-only
Aug 08, 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 II 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. In addition will process claims for financial reimbursement and replacement products in accordance with Allergan’s reimbursement policy.
Main Areas of Responsibilities
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. Conduct regulatory reporting in accordance with applicable regulations, Retrieval Program, and internal trending. Make reportability decisions within specified timelines.
Generate and submit MedWatch and PSR reports and forms to FDA within specified deadlines.
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).
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\
Provide generalized company, departmental and product knowledge as required.
Handle patient inquiries about clinical studies from internal and external customers.
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.
Respond to Clinical Study questions from internal and external customers.
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 assistance with various departmental projects that may include:
Write/revise department procedures as assigned.
Assist in the coordination of department personnel regarding MDR decisions to ensure compliance with applicable regulations.
Train new staff and conduct training/re-training on company policies, MDR regulations, and departmental practices.
Support the department on special projects as needed.
Assist in performing complaint audits.
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.
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.
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 demonstrate leadership in job performance by example.
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 coordinate and synchronize multiple projects.
Ability to manage a high-volume case load.
Ability to think critically and analytically to evaluate each record on a case-by-case basis.
- AA degree, with three to five years previous experience in customer service or clinical setting; or equivalent combination of education and experience. Bachelor’s degree is strongly 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.