AbbVie Product Surveillance Technician II in Austin, Texas
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 (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
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.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
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.
“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.”
Education and Experience
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.
Significant Work Activities
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.
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