Product Surveillance Rep I

Austin, TX, United States
Sep 05, 2020
Required Education
Associate Degree
Position Type
Full time
About AbbVie
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 . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description


"I'm looking for a budding leader, deadline juggler, and team player with experience in Post-Market Surveillance. If you want to jump start your path to leadership and contribute to keeping patients safe, I would be very interested in receiving your resume. Let's discuss what you can bring to the team and what you aspire to do in the future."

*YOU ARE more than just a title, YOU ARE...

• A Troubleshooter- You will investigate and maintain complaint files and analyze information obtained and make decisions for reportability under MDR regulation, 21 CFR 803, and international regulations
• A Critical Thinker - You are inquisitive and like solving problems. You will investigate and maintain complaint files, tack files sent to Quality Assurance, and evaluate further investigation results, documenting conclusions.
• A Knowledge Sponge - You develop and maintain a working knowledge base of MDR regulations, guidelines, interpretations, product labeling, and other laws and regulations.

• Be a process guru. Process outgoing faxes, incoming mail, data entry, filing, and copying
• Initiate and set up complaint files. Maintain and update databases, recording all complaint activity in both hard copy and digitally. You will code complaint information according to Post Market Spreadsheet Report, Retrieval Program, internal trending, and PMA Annual Updates. Make reportability decisions within timeline.
• Act as a Subject Matter Expert. Work cross functionally and communicate sensitive information appropriately with patients and physicians.
• Initiate product reimbursement and claim records. Work with multiple cases at a time and be able to identify potential litigious customers, escalating for appropriate resolution.
• Be a key participant in department projects.


• At least two (2-3) years of business experience within customer service or clinical setting.
• Associates degree required, Bachelor's degree from accredited college or university preferred or a combination of education and relevant experience.

For this role, we're looking for a thought leader who is:
• Excellence Focused
• Inquisitive
• Acts as an Owner

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.