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 AbbVies policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVies codes of conduct and compliance processes including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties as requested

Qualifications :

• Bachelors 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.
• Knowledge of FDA Quality Systems pharmaceutical products and Medical Device Reporting regulations (21 CFR 803 820 and 211) 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.

Additional Information :

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 AbbVies 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  or speaking with your Recruiter and well make any necessary adjustments to accommodate your needs.

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 doesnt 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. Were never satisfied with good enoughpatients 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 Companys 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. 

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Work :

No

Employment Type :

Full-time