Reporting Specialist II

The Reporting Specialist II 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. They will also manage through more complex reporting needs and are expected to be a subject matter expert. The individual will provide mentorship and support to the Reporting Specialist I team members.

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 and effectively communicate throughout
• Manages more complex reporting needs and external requests (i.e. from the FDA)
• Manage the timeline for end to end reporting
• Owns translation services for reporting
• Seeks efficiencies and ways to continuously improve our existing processes
• Provide mentorship to Reporting Specialist I team members