Reporting Specialist, Post Market Quality Assurance – JAPAC

2 weeks ago

North Sydney Council, Australia AbbVie Full time

Company Overview

AbbVie is a leading biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. Our mission is to have a remarkable impact on people's lives across various therapeutic areas, including immunology, oncology, neuroscience, and eye care.

Job Summary

The Reporting Specialist, Post Market Quality Assurance – JAPAC is responsible for executing all reporting activities in partnership with internal and external stakeholders. This role will partner with internal teams, including pharmacovigilance, local in-country teams, and the device quality assurance team, to ensure accurate and timely reporting of complaints.

Key Responsibilities

  • Make informed decisions regarding reportability
  • Lead all vigilance reporting, including local and global submissions
  • Collaborate with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalate requests as necessary
  • Ensure relevant stakeholders have visibility into the reporting process
  • Manage regular reporting needs and external requests
  • Oversee the timeline for end-to-end reporting
  • Own translation services for reporting
  • Coordinate device return activities
  • Support with vigilance data collection and review for weekly and monthly reports, management review meetings, CAPA, etc.
  • Support with PMQA-related activities, such as SOP review, CAPA, change controls, and audits

Requirements

  • Bachelor's Degree in a life science, pharmacy, nursing, or other scientific field
  • 5+ years of experience in a cGMP-related industry or clinical setting
  • Strong knowledge of TGA and Medsafe adverse event reporting processes, TGA Incident Reporting and Investigation Scheme (IRIS), and Medical Device Incident Reporting (MDIR) system
  • Knowledge of ASEAN and 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)
  • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures
  • Solid written and verbal communication, analytical, and organizational skills
  • Knowledge and application of computer systems for word processing and complaint management

AbbVie's Commitment to Diversity and Inclusion

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 actively encourage applications from individuals of all ages, nationalities, abilities, and cultures.

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