The Reporting Specialist I is responsible for executing all of the reporting, 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.
•Decision maker for all 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 reporting
•Owns translation services for reporting
•Bachelor’s Degree required; 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 an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.