Global R&D QA - Patient Safety Partner Compliance Specialist
Chiesi
Overview
In this role you will safeguard pharmacovigilance quality across corporate and affiliate levels, ensuring compliance with regulations and internal standards. You will drive deviations management, CAPA, and change control within the PV QMS, collaborating with QPPV and cross-functional teams. You'll help prepare inspections and maintain PV systems and documentation, contributing to regulatory readiness and continuous improvement. This is a globally oriented position rooted in a sustainability-driven, patient-focused culture.
Retribuzione / Benefits
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- relocation support
- annual bonus
Responsabilità
- Manage pharmacovigilance deviations identified through compliance monitoring
- Monitor the implementation of CAPAs from audits and deviations
- Inform the QPPV of non-conformities status identified via compliance monitoring
- Review PV System SOPs/WIs for compliance with PV regulations and internal standards
- Draft SOPs/WIs related to pharmacovigilance quality assurance activities
- Support preparation, management, and follow-up of inspections/audits by regulators and partners
- Collaborate on data collection and metrics/KPIs for the PV QMS
- Manage and support changes applicable to the PV System
- Collaborate on updating and review of the PSMF with PV QMS information
- Support maintenance of PV suppliers' qualification within company systems
- Update and maintain PV QMS tools and company systems in line with regulatory requirements
Requisiti fondamentali
- Degree in Life Sciences
- 3–5 years in pharmacovigilance and/or QA in pharma
- 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
- strong communication
- stakeholder collaboration
- attention to detail
- PV QMS
- deviations handling
- CAPA
Offerta di lavoro pubblicata 1 giorno fa
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