Global R&D QA, Senior PV Auditor
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. Discover more here.
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
• To verify that the quality system implemented both at Global and Affiliate level is coherent and compliant with internal procedures and regulatory requirements.
• To ensure continuous improvement of the quality processes at Global and Affiliate level with regard to Pharmacovigilance.
You will be responsible for
- To manage PV Audits to Chiesi Pharmacovigilance System (PV System and PV process Audits to Global Pharmacovigilance and Affiliates, PV Audits to Business Partners, PV Qualification and Maintenance Audits to Service Providers, PV Audit to PASS), including the risk-based planning, the audit conduction and the monitoring of the CAPA implementation and effectiveness;
- To contribute to the development and execution of the global PV audit strategy (both long-term and annual planning)
- To cooperate in the selection and management of the PV QA Service Providers;
- To review the PV SOPs related to the PV System to ensure harmonization and compliance with current regulations and corporate requirements;
- To write SOPs/WIs related to the PV Audits activities;
- To cooperate in the planning and execution of PV Audit trainings to Global and Affiliates PV personnel;
- To cooperate in the maintenance and the quality review of the PSMF;
- To act as QA PV partner providing expert inputs in the projects/activities for Global Patient Safety and Chiesi affiliates personnel;
- To cooperate to manage quality metrics for PV Audits
- To 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 Pharmacovigilance Auditor Consultant involved in international projects.
- As alternative, at least 5+ experience in Global PV System management and/or Quality Management System and compliance activities applicable to Pharmacovigilance system in pharmaceutical companies or in PV Service Providers.
- Scientific Master’s degree
- English fluent
- Knowledge of GVP Modules, ICH and ISO principles
- Knowledge of PV Quality Management Systems in Headquarters of international pharmaceutical companies
- Knowledge of pharmacovigilance processes of Global PV System
- Knowledge of auditing technique
- Knowledge of training technique
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.
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