ph3Supporting Patient Safety and Pharmacovigilance Excellence /h3 pAt 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.
/p pWe 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.
/p h3Why Join Shionogi?
/h3 pShionogi 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.
/p h3About the Role /h3 pAs 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.
/p h3Key responsibilities include: /h3 ul liSupporting the maintenance and update of the Pharmacovigilance System Master File (PSMF) /li liSupporting oversight of PV vendors, including review of deliverables and compliance checks /li liContributing to the preparation and quality control of Pharmacovigilance Agreements /li liPerforming quality control activities for PV trackers and compliance processes /li liSupporting reconciliation activities with internal stakeholders and external vendors /li liContributing to the monitoring of PV compliance metrics and KPIs /liliContributing to the development and maintenance of PV SOPs and working instructions /li liSupporting inspection and audit readiness activities, including documentation and follow-up actions /li liAssisting with CAPA management, implementation and tracking /li liSupporting in case processing, including data entry, quality review and follow-up in line with regulatory timeline /li liactivities and safety case follow-up /li liSupporting the review of medical information enquiries and product quality complaints for safety relevance /li liSupporting timely intake and triage of safety information through PV mailbox /li liProviding general support to PV operational activities as needed /li /ul h3What Are We Looking For?
/h3 pWe 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.
/p h3You will bring: /h3 ul liRelevant experience in pharmacovigilance within the pharmaceutical industry /li liBasic knowledge of pharmacovigilance regulations (e.g. GVP) and GxP principles /li liFamiliarity with PV processes such as case processing, reconciliations and compliance monitoring /li liExperience with PV systems and tracking tools is an advantage /li liStrong organisational skills and attention to detail /li liAbility to manage multiple tasks and prioritise effectively in a dynamic environment /li liDegree in a scientific discipline (e.g. Pharmacy, Life Sciences or similar) /li liGood communication and interpersonal skills /li liFluency in English, written and spoken /li liProficiency in Microsoft Office tools /li liProactive attitude and willingness to learn in a collaborative team environment /li /ul h3Join Us /h3 pJoin 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.
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📌 Pharmacovigilance Specialist (Salary €40-45K) (Lazio)
🏢 Shionogi Europe
📍 Lazio