PSMF & Compliance Manager

15 set - Parma
Chiesi

Overview

In this role you will support GRAPS to ensure the pharmacovigilance system aligns with regulatory expectations. Based at the Parma headquarters with hybrid work, you will help maintain PSMF readiness, monitor PV KPIs, and report on global PV performance. You will interact with stakeholders worldwide to implement PV improvements and advise on changes to keep the system compliant. This is a chance to shape pharmacovigilance processes within a global, sustainability-focused organization.

Retribuzione / Benefits

- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- remote work options
- annual premio scheme

Responsabilità

- Evaluate and apply pharmacovigilance regulations and guidelines to the company's PV system
- Ensure the PSMF is up-to-date by collecting stakeholder documents and advising on amendments
- Contribute to defining and improving PV KPIs and monitoring/reporting processes




- Track PV metrics and trends, address compliance issues, and support issue resolution
- Deliver KPI and PSMF reports to stakeholders for Global PV system assessment
- Collaborate with QPPV and other stakeholders on PV system improvements

Requisiti fondamentali

- Master Degree in life sciences, pharmacy or related fields
- Minimum 5 years of international Pharmacovigilance experience in pharma/biotech or CRO
- Proven ability in effective communication
- Strong decision making and problem solving
- Team working and cross-functional collaboration

- Effective communication
- Decision making
- Team working
- Pharmacovigilance regulations and guidelines
- PSMF management and governance
- PV KPI definition and reporting

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