Senior Manager, Pharmacovigilance Quality Assurance Audit

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

Purpose:
Describe the primary goals, objectives or functions or outputs of this position.
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 PVQA quality
system. Provision of advice and support on PV and quality topics to business partners to ensure
compliance with worldwide PV requirements and expectations.

Responsibilities:

• Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA oversight activities.
• Contributes to the delivery of innovative quality strategies and solutions through collaboration with
• business partners and other GxP RDQA functions to support effective and timely solutions to
• compliance issues and/or questions.
• Contributes to development and continuous improvement of necessary PV systems to assure
• compliance to worldwide regulations and corporate policies.
• Advances the AbbVie Quality System through contribution to the development and
• implementation of systems and processes required to support global quality assurance
• requirements.
• Contributes to the PV audit program by planning and, executing PV audits and working with
• auditees to resolve any non-compliance identified.
• Actively participates in and supports PV inspections onsite or remotely to ensure that PV
• inspecti