Reporting Specialist, Post Market Quality Assurance – JAPAC (12M Contract)

at  AbbVie

Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

QUALIFICATIONS

• 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)
• Strong Knowledge of TGA and Medsafe Adverse event reporting process, TGA Incident Reporting and Investigation Scheme (IRIS) & Medical Device Incident Reporting (MDIR) system.
• Knowledge of ASEAN & 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, analytical and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
  Additional Information

LET’S CREATE A MORE INCLUSIVE WORLD TOGETHER

AbbVie is dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We strongly believe that diverse perspectives are essential for achieving exceptional outcomes, and we actively encourage applications from individuals of all ages, nationalities, abilities, and cultures. We are committed to providing equal opportunities for all employees and ensuring a fair and inclusive recruitment process. If you have any specific requests or accessibility requirements, please inform us at the time of application (via anzhr@abbvie.com), and we will make the necessary adjustments to accommodate your needs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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PURPOSE

The Reporting Specialist I 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.

RESPONSIBILITIES

• Decision maker for 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 FDA)
• Manage the timeline for end to end reporting
• Owns translation services for reporting
• Coordinate Device return activities.
• Support with vigilance data collection and review for weekly & monthly reports, Management Review meetings, CAPA, etc.
• Support with PMQA related activities as SOP review, CAPA, Change Controls, Audits.
  Qualifications