20 set - Parma
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 premio
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
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