Specialist, Reporting I
2 weeks ago
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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