Pharmacovigilance Specialist
Pubblicato il 26-10-2026 - Shionogi Europe in Roma
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 with CAPA management, implementation and tracking
- Supporting in case processing, including data entry, quality review and follow-up in line with regulatory timeline
- activities and safety case follow-up
- Supporting the review of medical information enquiries and product quality complaints for safety relevance
- Supporting timely intake and triage of safety information through PV mailbox
- Providing general support to PV operational activities as needed
What Are We Looking For?
We are looking for a detail-oriented and proactive professional who is eager to develop within pharmacovigilance and contribute to a high-performing patient safety function.
You will bring:
- Relevant experience in pharmacovigilance within the pharmaceutical industry
- Basic knowledge of pharmacovigilance regulations (e.g. GVP) and GxP principles
- Familiarity with PV processes such as case processing, reconciliations and compliance monitoring
- Experience with PV systems and tracking tools is an advantage
- Strong organisational skills and attention to detail
- Ability to manage multiple tasks and prioritise effectively in a dynamic environment
- Degree in a scientific discipline (e.g. Pharmacy, Life Sciences or similar)
- Good communication and interpersonal skills
- Fluency in English, written and spoken
- Proficiency in Microsoft Office tools
- Proactive attitude and willingness to learn in a collaborative team environment
Join Us
Join Shionogi and contribute to safeguarding patient safety while developing your career within pharmacovigilance. If you are motivated by quality, collaboration and making a meaningful impact in healthcare, we would welcome your application.