Global R&D QA - Patient Safety Partner Compliance Specialist

Job description

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 ensure that the pharmacovigilance quality system, implemented at the corporate and affiliate levels, complies with applicable regulatory requirements and company quality standards. You will be responsible for Manage pharmacovigilance deviations identified through compliance monitoring Monitor the implementation of CAPAs resulting from audits and deviations Inform the QPPV of the status of non-conformities identified through compliance monitoring Review the PV System’s SOPs/WIs to ensure compliance with applicable pharmacovigilance regulations and internal quality standards Draft SOPs/WIs related to pharmacovigilance quality assurance activities Support the preparation, management, and follow-up of inspections/audits by regulatory authorities and partners Collaborate on data collection and the development of metrics/KPIs related to the PV QMS Manage and support the changes applicable to the PV System Collaborate on updating and review the PSMF with information related to the PV QMS Support the maintenance of the qualification status of pharmacovigilance suppliers within company systems Update and maintain company systems and tools used for PV QMS management, in accordance with regulatory requirements and company standards You will need to have Degree in Life Sciences (Pharmacy, Biology, Medicine, Biotechnology, Chemistry or equivalent) 3–5 years in pharmacovigilance and/or QA in pharma Hands-on experience with: PV QMS (deviations, CAPA, change control) SOP/WI writing and review Strong knowledge of GVP / PV regulations (EMA/FDA) Understanding of PSMF and PV systems Experience with quality systems and PV tools/databases Ability to manage compliance monitoring and metrics/KPIs Strong communication with stakeholders incl. QPPV interface English fluent We would prefer for you to have Experience in global/matrix pharma environment Exposure to regulatory inspections (EMA/FDA) Audit/inspection support Supplier qualification in PV Knowledge of ICH guidelines Location The position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options. Compensation range The minimum salary for this role is €46.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more 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.