Global R&D QA - Patient Safety Partner Compliance Specialist

Global R&D QA - Patient Safety Partner Compliance Specialist Department: Global R&D Quality Assurance

Business Area: Quality

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

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 including QPPV interface

We would prefer for you to have

Experience in global/matrix pharma environment

Exposure to regulatory inspections (EMA/FDA)

Audit/inspection support

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.

EEO Statement 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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