PpSelect how often (in days) to receive an alert: /p pDepartment: Global RD Quality Assurance /p pBusiness Area: Quality /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p h3About us /h3 pChiesi 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. /p pAt 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 Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity 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. /p h3Chiesi Research Development /h3 pOur RD 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, RD 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). /p h3This is what you will do /h3 ul liTo verify that the quality system implemented both at Global and Affiliate level is coherent and compliant with internal procedures and regulatory requirements. /li liTo ensure continuous improvement of the quality processes at Global and Affiliate level with regard to Pharmacovigilance. /li /ul h3You will be responsible for /h3 ul liTo 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; /li liTo contribute to the development and execution of the global PV audit strategy (both long-term and annual planning) /li liTo cooperate in the selection and management of the PV QA Service Providers; /li liTo review the PV SOPs related to the PV System to ensure harmonization and compliance with current regulations and corporate requirements; /li liTo write SOPs/WIs related to the PV Audits activities; /li liTo cooperate in the planning and execution of PV Audit trainings to Global and Affiliates PV personnel; /li liTo cooperate in the maintenance and the quality review of the PSMF; /li liTo act as QA PV partner providing expert inputs in the projects/activities for Global Patient Safety and Chiesi affiliates personnel; /li liTo cooperate to manage quality metrics for PV Audits /li liTo engage with QPPV, senior QA/PV leaders, and cross‑functional stakeholders /li /ul h3You will need to have /h3 ul liAt least 5+ years experience as Pharmacovigilance Auditor in Pharmaceutical Companies or as Pharmacovigilance Auditor Consultant involved in international projects. /li liAs 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. /li liKnowledge of GVP Modules, ICH and ISO principles /li liKnowledge of PV Quality Management Systems in Headquarters of international pharmaceutical companies /li liKnowledge of pharmacovigilance processes of Global PV SystemKnowledge of auditing technique /li liKnowledge of training technique /li /ul h3Location /h3 pItaly, with possibility of smart working /p h3What we offer /h3 pNo 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. /p pWe 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. /p pChiesi 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. /p /p #J-18808-Ljbffr