Post Market Quality Assurance Reporting Specialist
* Full-time
* Workday Global Grade: 14
The Post Market Quality Assurance Reporting Specialist is responsible for executing all quality reporting activities in partnership with internal and external stakeholders. The individual will partner with internal teams including pharmacovigilance, local in‐country teams, and the device quality assurance team to ensure appropriate and accurate reporting of complaints. The role interfaces with regulators and serves as the liaison to the respective team when questions and requests arise.
NOTE: This role is a 12‐month maximum term contract.
Key Duties and Responsibilities
* 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 stakeholders have visibility into the reporting process.
* Manage regular reporting needs and external requests (e.g., 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.
* 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.
* Adhere to AbbVie's codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
* Perform other ad hoc duties such as administrative tasks as requested.
Qualifications
* Bachelor's degree strongly preferred; preferably in 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 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.
* Solid written and 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.
AbbVie is an equal opportunity employer, dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We ensure a fair and inclusive recruitment process without discrimination based on race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Legal compliance, integrity, and diversity are core values.
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