07 set - Latina
Shionogi Europe
Supporting Patient Safety and Pharmacovigilance Excellence At Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence. As our European organisation continues to grow, we are strengthening our pharmacovigilance (PV) capabilities to ensure the highest standards of patient safety and regulatory compliance.
We are now seeking a Pharmacovigilance Specialist to support the delivery of operational PV activities across Europe and contribute to the continuous improvement of our pharmacovigilance system. This is an important role focused on ensuring compliance, accuracy and quality in all safety-related processes.
Why Join Shionogi? Shionogi offers a purpose-driven, agile environment where individuals are empowered to make a meaningful impact. This role provides excellent exposure across the European organisation, collaboration with experienced PV professionals, and the opportunity to develop within a growing and dynamic function.
About the Role As Pharmacovigilance Specialist, you will support the execution of pharmacovigilance activities,
ensuring compliance with regulatory requirements and internal procedures, while contributing to maintaining high standards in patient safety and data quality.
Key responsibilities include:
- Supporting the maintenance and update of the Pharmacovigilance System Master File (PSMF)
- Supporting oversight of PV vendors, including review of deliverables and compliance checks
- Contributing to the preparation and quality control of Pharmacovigilance Agreements
- Performing quality control activities for PV trackers and compliance processes
- Supporting reconciliation activities with internal stakeholders and external vendors
- Contributing to the monitoring of PV compliance metrics and KPIs
- Contributing to the development and maintenance of PV SOPs and working instructions
- Supporting inspection and audit readiness activities, including documentation and follow-up actions
- Assisting w
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