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Job Details

Representative Product Surveillance I

Company name
Allergan, Inc

Location
Austin, TX

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Profile

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 pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.

Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right. 

Join one of the world’s fastest growing pharmaceutical companies! 

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description

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.  In addition will process claims for financial reimbursement and replacement products in accordance with Allergan’s reimbursement policy.

“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.”

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.

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

Process Support Process outgoing faxes, incoming mail, perform data entry, filing and copying.

Inform patients and doctors of product return requirements.

Ability to identify potentially litigious customers, and forward to management for resolution.

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.

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.

Support the department on special projects as needed. Requirements

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.

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 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 participate in 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.

Education

AA degree; Bachelor’s degree is preferred.

Job Requirements

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Company info

Allergan, Inc
Website : http://www.allergan.com

Company Profile
Allergan, Inc. operates as a multi-specialty health care company primarily in the United States, Europe, Latin America, and the Asia Pacific. The company discovers, develops, and commercializes pharmaceutical, biological, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, urological, and other specialty markets. It operates in two segments, Specialty Pharmaceuticals and Medical Devices. The Specialty Pharmaceuticals segment produces a range of pharmaceutical products, including ophthalmic products for dry eye, glaucoma, inflammation, infection, allergy, and retinal disease; Botox for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, eyelash growth, and other prescription and physician-dispensed skin care products; and urologics products. The Medical Devices segment offers a range of medical devices, such as breast implants for augmentation, revision, and reconstructive surgery, as well as tissue expanders; and facial aesthetics products. The company sells its products to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass merchandisers, food stores, hospitals, group purchasing organizations, integrated direct hospital networks, ambulatory surgery centers, government purchasing agencies, and medical practitioners. It focuses on eye care professionals, neurologists, physiatrists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, urologists, urogynecologists, and general practitioners. The company has collaboration agreements with Molecular Partners AG; Spectrum Pharmaceuticals, Inc.; and Serenity Pharmaceuticals, LLC. Allergan, Inc. was founded in 1948 and is headquartered in Irvine, California.

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