Post Market Quality Assurance Reporting Specialist

The Post Market Quality Assurance Reporting Specialist is responsible for executing all reporting in partnership with internal and external stakeholders. The individual will partner with internal teams such as pharmacovigilance, local in‑country teams, and the device quality assurance team to ensure appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison when questions and requests arise.

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

• Decision maker for all reportability decisions.
• Lead for all vigilance reporting, including local and global submissions.
• Partner with pharmacovigilance, regulatory affairs, in‑country teams, and device QA for submissions and escalates requests as appropriate.
• Ensure that relevant stakeholders have visibility to the reporting and where they are in the process.
• Manage regular reporting needs and external requests (i.e. from the TGA, Medsafe, and other applicable local regulatory authorities in assigned Asia markets).
• Manage 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.

• Bachelor’s Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background.
• 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred).
• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products, with working knowledge of ANZ requirements and preference for exposure to regulatory expectations in Asia markets.
• Knowledge of TGA and Medsafe quality system requirements and Medical Device Reporting regulations and guidelines is required.
• Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211), or exposure to comparable international reporting frameworks and local country requirements in Asia markets, is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross‑functional teams and to interact effectively with peers, management, and customers.

In line with Australia’s “Right to Disconnect” legislation, we recognise and respect employees’ right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

AbbVie is an equal‑opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status.