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

• 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.

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. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing [email protected] or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

Flexibility and Availability: 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.

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

• AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers. 
• AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws. 
• All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law. 
• Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal. 
• AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html