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About the Role

The Post Market Quality Assurance Reporting Specialist is responsible for executing all reporting in partnership with internal and external stakeholders. This role will interface with regulators and serve as the liaison when questions and requests arise. This is a 12-month maximum term contract.

Responsibilities

• Execute all reporting in partnership with internal and external stakeholders.
• Partner with pharmacovigilance, local in-country teams, and the device quality assurance team to ensure appropriate and accurate reporting of complaints.
• Interface with regulators and serve as the liaison to the respective team when questions and requests arise.
• Act as decision maker for all reportability decisions.
• Lead all vigilance reporting, including local and global submissions.
• Partner with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalate requests as appropriate.
• Ensure relevant stakeholders have visibility to reporting status.
• Manage regular reporting needs and external requests from 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.
• Perform other ad hoc administrative duties as requested.

Requirements

• 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.
• Working knowledge of ANZ requirements.
• 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 interact effectively with peers, management, and customers.

Skills

• Communication skills
• Organizational skills
• Computer systems for word processing
• Complaint management systems

Location

• Asia markets

Work Type

• Contract

Experience Level

• 5+ years

Education Level

• Bachelor's Degree

About the Company

• AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
• We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
• 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.
• AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

Equal Opportunity

• 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.
• 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.