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Complaint Processing Analyst I
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AbbVie

Complaint Processing Analyst I

Onsite Costa Rica Full Time
Posted an hour ago
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powertofly approved What AbbVie Has to Offer:

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.

Job Details


Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.


Job Description

  • Assure complaint records meet global requirements.
  • Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
  • Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
  • Identification of potentially reportable events and notification to appropriate functional groups and management.
  • Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.

Qualifications

  • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
  • Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
  • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
  • Solid written/verbal communication and organizational skills.
  • Knowledge and application of computer systems: MS word,excel
  • Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
  • A Bachelor Degree required or 1-2 years of relevant work experience. (Preferred degree in technology or scientific background)
  • 0-2 years’ work experience in a cGMP ( Good Manufacturing Practice) related industry or in a clinical setting (preferred).
  • English B2+

Additional Information

At AbbVie, we are committed to cultivating a work culture that promotes inclusion, diversity and personal growth. We recognize that our collective success is based on the individual well-being of our employees and that is why we have designed a benefits package with every aspect of their lives in mind.
Enhanced Health and Wellness Coverage: Our administrative staff has comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones.
Life Insurance: Secure your family's future with our life insurance policy.
Solidarity Association: Join a community focused on mutual aid and enjoy the benefits that come with being a member.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Details
AbbVie
 Chicago, IL, United States
Work at AbbVie

Together, we break through We believe the paths we take to achieving our breakthroughs matter. At AbbVie, every one of our 50,000 employees is a... Read more

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