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 reporting and where they are in the process.
• Manages regular reporting needs and external requests (i.e. from the TGA, Medsafe, and other applicable local regulatory authorities in assigned Asia markets).
• Manages the timeline for end-to-end reporting.
• Support the return of complaint-related devices for investigation and analysis purposes.
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested