Reporting Specialist I

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.

Candidate must be onsite in Tempe AZ in a hybrid schedule: Tuesday-Thursday. 

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 reporting
• Owns translation services for reporting

Qualifications :

• Bachelors 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.

#LI-JW1

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

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

Work :

No

Employment Type :

Full-time