Global R&D QA, Senior PV Auditor Parma, Italy (43126)
Location: Parma, IT (Remote possible)
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.
Who we are looking for This is what you will do
Verify that the quality system implemented 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, audit conduction, 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 the PV QA Service Providers.
Review PV SOPs related to the PV System to ensure harmonization and compliance with current regulations and corporate requirements.
Write SOPs/WIs related to the PV audit activities.
Cooperate in the planning and execution of PV audit trainings to Global and Affiliates PV personnel.
Cooperate in the maintenance and quality review of the PSMF.
Act as QA PV partner providing expert inputs in projects/activities for Global Patient Safety and Chiesi affiliates personnel.
Cooperate to 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 Pharmacovigilance Auditor Consultant involved in international projects.
Alternatively, at least 5 years experience in Global PV System management and/or Quality Management System and compliance activities applicable to Pharmacovigilance system.
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 We provide top‑class benefits, comprehensive healthcare programs, work-life balance initiatives, robust relocation support, competitive salary packages, flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.
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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