Post Market Quality Assurance Reporting Specialist

The Post Market Quality Assurance Reporting Specialist 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.

NOTE: This role is a 12 months max term contract.

KEY DUTIES AND RESPONSIBILITIES

• 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...