Analyst, Device Tracking I
Acerca de AbbVie
La misión de AbbVie es descubrir y entregar terapias innovadoras que resuelvan problemas severos de salud y aborden los desafíos médicos del mañana. Nos esforzamos por tener un impacto notable en la vida de las personas en áreas terapéuticas clave: inmunología, oncología, neurociencias, cuidado de la visión, virología, salud de la mujer y gastroenterología, además de productos y servicios del portafolio de Allergan Aesthetics. Para obtener más información sobre AbbVie, visítenos en www.abbvie.com . Sigue a @abbvie en Twitter , Facebook , Instagram , YouTube y LinkedIn .
Under general direction, the Device Tracking Analyst I will perform a variety of complex duties associated with supporting device tracking activities to ensure device tracking files are maintained and reconciled. The Device Tracking Analyst will communicate with customers to obtain and/or verify device tracking information in compliance with device tracking regulations established by the FDA and international regulatory bodies. He/she will facilitate actions identified to improve customer experience and patient safety. He/she will participate and/or lead in the identification and implementation of device tracking management system improvements, including technical support, and updates to procedures and forms used in the device tracking process. Assist globalization of requirements, where necessary. The individual is a subject matter expert due to demonstrated excellence in work performance and mastery of the knowledge, tasks, and skill sets. Works with little to no supervision.
Responsibilities of this role include:
- Process and maintain device tracking files in the device tracking system to support compliance with device tracking regulations and internal procedures.
- Initiate device tracking files when forms are received in a timely manner. Maintain and update device tracking system. Record all activity in both hard copy (when applicable) and computer files.
- Maintain a knowledge and understanding of current Device Tracking regulations, Device Tracking guidelines, and Device Tracking interpretations.
- Coordinate with inter- and intra-departmental customers to ensure device tracking information and inquiries are communicated appropriately.
- 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 department processes and workflow.
- Monitor multiple files at once, including status and follow-up as necessary.
- Respond to verbal and written requests from internal and external customers.Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files, following complaint handling regulations 21 CFR 820.198, and SOR/98-282, and internal procedures.
- Support the department on special projects as needed.
Education and Experience
- AA degree; Bachelor's degree is preferred.
- 3 years previous experience in customer service or clinical setting; or equivalent combination of education and experience.
- Knowledge in device tracking policies and requirements. Ability to understand the impact of regulatory compliance requirements (e.g. 21 CFR 821, 21 CFR Part 11, SOR/98/282 and other regulations as they apply)
- Ability to function in a controlled environment by the FDA and other regulatory authorities.
- Must have effective written/verbal, interpersonal, organizational skills.
- Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
- Ability to work effectively with a diverse network of internal and external departments and/or individuals.
- Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
- Skill in demonstrating a professional phone manner.
- Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
- 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 think critically and analytically.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Tipo de trabajo
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.