Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.

Job Description

Individual will lead the Global Complaint team which processes product complaints and inquiries with a focus on AbbVie post market products. Will manage complaints from both the Legacy AbbVie and Legacy Allergan portfolios in a global capacity. Interface with internal and external AbbVie customers such as physicians, nurses, pharmacists, hospital personnel, risk managers,  purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and Pharmacovigilance regarding AbbVie product complaints. Responsible for oversight of product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Also will support cross training on other products such as pharma/combo as needed for business needs.

Responsibilities:

Provide direction for the complaint processing team. Has a future focused perspective to ensure we are staying ahead of trends.Influence the teams to have an aligned and consistent approach with complaint handling.Oversee global and US complaint processing methods to ensure complaints related to medical devices, combination products, pharmaceutical and biologics products are appropriately handled, and evaluated.Assure complaint records meet global requirements and ensure the team is staying up to date on current obligations.Assure complaint records meet global requirements.Identification of potentially reportable events and notification to appropriate functional groups. Lead efforts to resolve.Ability to create formal documentation that meets GMP standards and can be used for regulatory filings and/or reporting.  Examples include: Form 3500A and Med Dev.Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.Oversight of management of a project team or participation on a project team involving process improvements, new product launches, issue resolutions, etc.
Qualifications

Qualifications:

Bachelor’s Degree required; preferably in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN). 6+ years of work experience in a cGMP related industry or in a clinical setting (preferred) 2 years of management experience preferred.Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.Knowledge of FDA 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. (C1 English level)Knowledge and application of computer systems for word processing and complaint management.Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
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.Flexible Hybrid Work Model: For eligible positions within our administrative staff, we adopt a hybrid work scheme that allows you the convenience of teleworking for two days a week.Life Insurance: Secure your family's future with our life insurance policy.Educational Advancement: Invest in your future with our scholarship program available to employees and theirdependents.Employee Assistance Program (EAP): Access professional support with our comprehensive EAP, which offers psychological, legal and financial counseling.Community and Social Commitment: Make a difference with a paid volunteer day, which allows you to contribute to the community during the company's working hours.Employee Stock Purchase Plan: Participate in our company's success by buying shares at a special price exclusive to employees.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, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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