06 ago
|
Experteer Italy
|
Parma
06 ago
Experteer Italy
Parma
ph3Experteer Overview /h3pIn 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.
/ph3Retribuzione / Benefits /h3ulliManage pharmacovigilance deviations identified through compliance monitoring /liliMonitor the implementation of CAPAs from audits and deviations /liliInform the QPPV of non-conformities status identified via compliance monitoring /liliReview PV System SOPs/WIs for compliance with PV regulations and internal standards /liliDraft SOPs/WIs related to pharmacovigilance quality assurance activities /liliSupport preparation, management,
and follow-up of inspections/audits by regulators and partners /liliCollaborate on data collection and metrics/KPIs for the PV QMS /liliManage and support changes applicable to the PV System /liliCollaborate on updating and review of the PSMF with PV QMS information /liliSupport maintenance of PV suppliers' qualification within company systems /liliUpdate and maintain PV QMS tools and company systems in line with regulatory requirements /li /ulh3Responsabilità /h3ulliDegree in Life Sciences /lili3–5 years in pharmacovigilance and/or QA in pharma /liliPV QMS (deviations, CAPA, change control) /liliSOP/WI writing and review /liliStrong knowledge of GVP / PV regulations (EMA/FDA) /liliUnderstanding of PSMF and PV systems /liliExperience with quality systems and PV tools/databases /liliAbility to manage compliance monitoring and metrics/KPIs /liliStrong communication with stakeholders incl.
QPPV interface /liliEnglish fluent /li /ulh3Requisiti fondamentali /h3ullipension /liliprivate medical insurance /liliwellbeing programme /liliflexible benefits programme /lilirelocation support /liliannual premio /li /ul /p #J-*****-Ljbffr
📌 Global R&D Qa - Patient Safety Partner Compliance Specialist (Parma)
🏢 Experteer Italy
📍 Parma