Reporting to: Head of Pharmacovigilance and Regulatory Services (HoPRS) Location: Hybrid working Hours of work: Full Time Secondment NWEH specialise in delivering clinical trials driven by Electronic Health Record (EHR) data. We are the world leaders in this field. By maintaining close relationships with academia and the NHS whilst working alongside global pharmaceutical companies we create new market standards for the evaluation of healthcare interventions. Located within Manchester Science Park, NWEH are looking for talented, innovative, and passionate people. This is an excellent opportunity to join a pioneering organisation, helping to redefine how electronic healthcare data is used to benefit patients and facilitate new models of clinical research. Job purpose: The Safety Nurse is responsible for the implementation and day-to day oversight of NWEH’s ConneXon safety strategies, supporting effective safety monitoring and reporting across designated clinical studies. The secondment role will ensure that pharmacovigilance (PV) activities are carried out in line with regulatory requirements and support the delivery of high-quality, real-world safety data through the ConneXon data platform. Throughout the secondment, during quieter periods you will also be required to support the Community Team with ad-hoc duties as needed. You will remain an active member of the team, continuing to participate in regular team meetings and ongoing activities. Key safety accountabilities: Responsibilities: Pharmacovigilance Oversight Oversee all safety-related activities linked to NWEH’s safety technologies, specifically the ConneXon Activity Summary ensuring adherence to safety monitoring guidelines and Good Clinical Practice (GCP). Advice and Support Act as the primary point of contact for study teams requiring advice or support in the use of the ConneXon Activity Summary. Process Development and Review Support the development, implementation, and regular review of safety-related processes, SOPs, and user guidelines to ensure best practice and regulatory compliance. Training Delivery Support the design and delivery of comprehensive training programmes for study staff on the use of NWEH’s safety technologies, ensuring competency in the use of ConneXon and associated reporting procedures. Reporting and Communication Provide timely and accurate safety reports and updates during project delivery meetings with the Head of Pharmacovigilance & Regulatory Services and other stakeholders as required. Activity Summary Management Ensure all safety alerts generated within the Activity Summary are actioned within 24 hours of awareness. Escalate overdue safety alerts in accordance with agreed timelines to the HoPRS and the Quality Team. Escalate technical issues arising from the Activity Summary to the Customer Support Team (CST) and the HoPRS for resolution and tracking. Work alongside the Product Manager for ConneXon to support ongoing development of the Activity Summary, including user experience improvements and feature enhancements aligned with safety reporting needs. Person Specification: Essential: Registered Nurse NMC Level 1 Minimum 5 years post registration experience Proven experience clinical safety monitoring, preferably within real-world or pragmatic trial settings Strong understanding of safety regulations and GCP Demonstrated ability to manage operational aspects of clinical safety systems and reporting tools Excellent communication and stakeholder engagement skills High attention to detail and ability to act promptly in managing safety-related issues Desirable: Experience working with digital health technologies or safety data platforms Experience in developing training materials and delivering training to clinical or operational teams Ability to influence and collaborate effectively across multidisciplinary teams