Pharmacovigilance Auditing Unit Head

Questa posizione è in Chiesi Group Riassunto dell'opportunità da parte della

Joinrs AI

:

Chiesi Group

ricerca un

Pharmacovigilance Auditing Unit Head

con almeno

5 anni di esperienza

in audit farmacovigilanza o gestione di sistemi PV globali. Il candidato guiderà gli audit PV, assicurerà la conformità normativa e collaborerà con team globali per migliorare i processi. Sono richiesti una laurea scientifica magistrale e conoscenza approfondita di GVP, ICH e sistemi di qualità PV. Offerte condizioni lavorative flessibili, inclusa la possibilità di smart working, e un pacchetto retributivo competitivo con benefit e formazione continue.

Il processo di selezione sarà interamente gestito da Chiesi Group. -- Pharmacovigilance Auditing Unit Head Date:

24 Jun 2026 Department:

Global R&D Quality Assurance Business Area:

Quality Job Type:

Direct Employee Contract Type:

Permanent Location:

Parma, IT About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Who we are looking for This is what you will do Verify that the quality system implemented both at Global and Affiliate level is coherent and compliant with internal procedures and regulatory requirements. Ensure continuous improvement of the quality processes at Global and Affiliate level with regard to Pharmacovigilance. You will be responsible for Manage PV Audits to Chiesi Pharmacovigilance System (including risk-based planning, conduction, and monitoring of CAPA implementation and effectiveness). Contribute to the development and execution of the global PV audit strategy (long-term and annual planning). Cooperate in the selection and management of PV QA Service Providers. Review PV SOPs to ensure harmonization and compliance with regulations and corporate requirements. Write SOPs/WIs related to PV Audits activities. Cooperate in planning and executing PV Audit trainings for Global and Affiliate PV personnel. Maintain and quality review of the Pharmacovigilance System Master File (PSMF). Act as QA PV partner providing expert inputs in projects and activities for Global Patient Safety and Chiesi affiliates personnel. Manage quality metrics for PV Audits. Engage with QPPV, senior QA/PV leaders, and cross-functional stakeholders. You will need to have At least 5 years experience as Pharmacovigilance Auditor in Pharmaceutical Companies or as Consultant involved in international projects. Alternatively, at least 5 years experience in Global PV System management and/or Quality Management System in Pharmacovigilance. Scientific Master’s degree. Fluent English. Knowledge of GVP Modules, ICH and ISO principles. Knowledge of PV Quality Management Systems in international pharmaceutical companies. Knowledge of pharmacovigilance processes of Global PV Systems. Knowledge of auditing and training techniques. Location Italy, with possibility of smart working What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. -- [#J-ENTERPRISE]