Senior Analyst, PQA

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Senior Analyst, Post-Market Surveillance is part of AbbVie’s Medical Device Center within the Shared Services function (“MDCSS”). This position’s primary focus is on Post-Market Risk, and reports to the Manager, Post-Market Device Quality (or equivalent).

The role performs a variety of tasks related to maintenance and post-market evaluation of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820, MDR 2017/745, EN ISO 13485). Primary responsibility is Post-Market Reporting (e.g., PMCF, PMSR, PSUR, etc.), however the role may also entail analyzing complaints, analyzing post-market signals, collecting data, and evaluating other measures of product performance (e.g., CAPA/NCR).

The Senior Analyst, Post-Market Surveillance serves as a cross-functional team advocate, tasked with
assuring stakeholder concerns are addressed during planning and/or execution of assigned activities.

• Assess trends escalated by Signal Detection, as assigned
• Conduct investigations for CAPAs, NCRs, Observations, etc.
•  Coordinate and schedule post-market reporting activities (e.g., CERs, PMCFP/PMCFR, PMSP/PMSR/PSURs, etc.)
• Author or update Post-Market Reporting documents (e.g., PMCFP/PMCFR, PMSP/PMSR/PSURs, PRER, etc.)
• Work with internal business partners to ensure timely collection and assessment of relevant data (e.g., complaint trends, literature reviews, medical assessments) to drive evidence-based conclusions regarding product performance and safety
• Escalate discrepancies and confirmed or potential Quality issues to management
• Develop Quality Plans and manage projects, as assigned
• Support interactions with regulatory autho