Pharmacovigilance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/80eis5

Supporting Patient Safety and Pharmacovigilance ExcellenceControlli attentamente tutta la documentazione richiesta per la candidatura prima di fare clic sul pulsante apposito in fondo a questa descrizione.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 RoleAs 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 checksContributing to the preparation and quality control of Pharmacovigilance AgreementsPerforming quality control activities for PV trackers and compliance processesSupporting reconciliation activities with internal stakeholders and external vendorsContributing to the monitoring of PV compliance metrics and KPIsContributing to the development and maintenance of PV SOPs and working instructionsSupporting inspection and audit readiness activities, including documentation and follow-up actionsAssisting with CAPA management, implementation and trackingSupporting in case processing, including data entry, quality review and follow-up in line with regulatory timelineactivities and safety case follow-upSupporting the review of medical information enquiries and product quality complaints for safety relevanceSupporting timely intake and triage of safety information through PV mailboxProviding general support to PV operational activities as neededWhat 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 industryBasic knowledge of pharmacovigilance regulations (e.G. GVP) and GxP principlesFamiliarity with PV processes such as case processing, reconciliations and compliance monitoringExperience with PV systems and tracking tools is an advantageStrong organisational skills and attention to detailAbility to manage multiple tasks and prioritise effectively in a dynamic environmentDegree in a scientific discipline (e.G. Pharmacy, Life Sciences or similar)Good communication and interpersonal skillsFluency in English, written and spokenProficiency in Microsoft Office toolsProactive attitude and willingness to learn in a collaborative team environmentJoin UsJoin Shionogi and contribute to safeguarding patient safety while developing your career within pharmacovigilance. xysqume If you are motivated by quality, collaboration and making a meaningful impact in healthcare, we would welcome your application.#J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/80eis5