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Global R&D QA - Patient Safety Partner Compliance Specialist
Job Description & How to Apply Below
Riassunto dell'opportunità da parte della Joinrs AI : Chiesi Group ricerca un Patient Safety Partner Compliance Specialist con laurea in Scienze della Vita per garantire la conformità del sistema di farmacovigilanza. Il ruolo prevede gestione delle non conformità, supporto agli audit e sviluppo di SOP/WI. I benefit includono contratto a tempo indeterminato, lavoro flessibile (ibrido o da remoto), bonus annuale e un pacchetto di welfare completo.
Il processo di selezione sarà interamente gestito da Chiesi Group.
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- Global R&D QA - Patient Safety Partner Compliance Specialist
Date: 25 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
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…
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