Global R&D QA

Questa posizione è in Chiesi Group

Riassunto dell'opportunità da parte della Joinrs AI :

Chiesi Group ricerca un Patient Safety Partner Compliance Specialist con laurea in Scienze della Vita per assicurare la compliance del sistema di farmacovigilanza ai requisiti regolatori. Il ruolo prevede la gestione di deviazioni, la revisione di SOP e il supporto in audit internazionali. Offerta a tempo indeterminato, con RAL a partire da €46.000, bonus annuale e pacchetto benefit completo tra cui assicurazione privata e programmi di benessere.

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 compliance monitoring and metrics/KPIs <