Job Description
Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and procedures wherever possible and leading the development and implementation of the AbbVie quality system. Leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provision of advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.
Assures quality and compliance in a regulated environment, leads PV audits, communicates audit results, and reviews Corrective Action Plans. Assists in the design of risk-based methodologies, contributes to the AbbVie Quality System, and provides critical audit related data for the Product Safety Master File. This role can be remote within the US or the UK.
About AbbVie
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.