About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The purpose of this role is to support the development, implementation, maintenance and monitoring of an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization that at a minimum meets global regulatory legal requirements and standards, and additionally promotes best practice and excellence. The role focuses on the pharmacovigilance investigation and CAPA processes. The scope extends to pharmacovigilance activities worldwide and spans the life cycle of all products. The Safety Compliance team partners with a wide range of stakeholders within PPS, across Research & Development, and the Commercial organization, engaging at both corporate and affiliate locations. Main Responsibilities: Conduct timely triage, impact assessment and investigation of issues, potential non-conformities, exceptions, and planned deviations using professional judgment and expertise; seek clarification and additional information from stakeholders as required to conduct the necessary assessments. Initiate and lead PV investigations; collaboratively working with stakeholders to appropriately investigate non-conformances and potential non-conformances using best practice methodologies to establish accurate root cause(s). Lead the development of appropriate and risk-proportionate actions with stakeholders that effectively address the root cause(s) of non-conformances and potential non-conformances. Provide stakeholder support and guidance in the conduct of high-quality PV investigations and CAPA best practice, developing positive working relationships while promoting a quality focused mindset. Process and implement planned deviations ensuring that all requests are appropriate, meet internal requirements and are completed within required timeframes. Verify completion and effectiveness of actions and ensure robust documentation. Ensure the effective tracking of exception reports, planned deviations and associated actions; liaise with stakeholders to ensure visibility of timelines and timely completion of actions. Support the execution of the PPS audit and inspection strategy, in collaboration with other members of the Safety Compliance function; may include coordination of logistics, providing subject matter expertise relating to PV investigation and CAPA processes Actively identify and propose process improvements while fully engaging in new initiatives to continually support the improvement of the PV investigation/CAPA and planned deviation process. Participate in PPS and cross-functional projects and initiatives related to quality management Qualifications Qualifications Bachelor’s degree or equivalent in health, science or quality field Required: proven pharmaceutical or quality system experience; preferred: practical pharmacovigilance experience Ability to function independently, influence a wide range of stakeholders and problem solve effectively Key Stakeholders: All PPS functional areas Affiliate Safety Representatives Other AbbVie quality and compliance functions e.g., RDQA, Clinical Compliance, Information Research Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.