Purpose

　　The Reporting Specialist I is responsible for executing intake complaint processes and reporting activities, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

　　Responsibilities

　　Decision maker for reportability decisions

　　Lead for all vigilance reporting, including local and global submissions

　　Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate

　　Ensures that relevant stakeholders have visibility to the reporting and where they are in the process

　　Manages regular reporting needs and external requests (i.e. from the FDA)

　　Manage the timeline for end to end complaint processes including reporting

　　Owns translation services for reporting

　　Qualifications

　　Bachelor’s Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background

　　5+ years of work experience in a cGMP related industry or in a clinical setting (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.

　　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.

　　AbbVie 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.