Specialist, Reporting I

2 weeks ago


Branchburg Township New Jersey, United States AbbVie Full time
Job Description

Purpose

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.

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



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