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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Safety Data Transformation Lead - **Company:** Clearline Recruitment Ltd - **Location:** Welwyn Garden City, UK - **Experience:** Expert - **Salary:** £62,088 - £99,840 - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Data Analysis, Data Transformation - **Published:** November 7, 2026 - **Apply:** https://www.adzuna.co.uk/jobs/details/5956425684 ## About the Role * Evidence of advanced learning, such as an undergraduate degree, although relevant on-the-job pharmacovigilance experience will also be considered * Strong knowledge of pharmacovigilance and ICSR case processing, including a broad understanding of the end-to-end ICSR process * Good understanding of international pharmacovigilance regulations, including ICH, EU GVP Modules and FDA requirements * Understanding of the pharmaceutical industry, including product development, the commercial environment and the evolving personalised healthcare landscape * Experience overseeing service providers and managing stakeholder relationships * Strong understanding of quality management, compliance, risk management and process improvement * Excellent communication and stakeholder management skills, with the ability to influence colleagues and communicate complex information clearly * A proactive, self-motivated approach, with the ability to work independently and make sound, compliant decisions * Strong problem-solving skills and the ability to identify root causes, manage issues and implement effective solutions * Ability to manage competing priorities and work effectively across virtual, co-located and matrix teams Additional Requirements: For the Safety Data Transformation Lead: * Proven experience leading complex, time-sensitive projects and initiatives * Experience working with a wide range of stakeholders and coordinating activities across multiple teams * Strong leadership, decision-making and problem-solving capabilities * Demonstrable experience working proactively and independently * Self-motivated with the ability to take ownership of tasks, identify opportunities and drive improvements Desirable Experience: * Experience with Medical Device processing and associated safety reporting requirements * Experience working with service providers and overseeing pharmacovigilance operations * Knowledge of emerging technologies, including Artificial Intelligence (AI) and opportunities to introduce human-in-the-loop solutions * Experience supporting regulatory inspections, audits and external stakeholder engagements ## Description This is a fantastic opportunity for an experienced Pharmacovigilance and Patient Safety professional to play a key role in transforming safety data processes and ensuring the accurate, compliant and high-quality processing of Individual Case Safety Reports (ICSRs). Working within the Patient Safety Operations - Data Transformation team, you will use your pharmacovigilance expertise to oversee safety data processes, drive continuous improvement and support the delivery of effective solutions that ultimately help protect patient safety., * Oversee service providers responsible for executing ICSR case processing activities and Medical Device reports * Act as a subject matter expert, answering queries and proactively sharing pharmacovigilance expertise with internal stakeholders, service providers, business partners, auditors and regulatory inspectors * Conduct process reviews to identify opportunities for improvement and design and implement more effective ways of working * Identify root causes of non-compliance and develop appropriate Corrective and Preventative Actions (CAPAs), including taking responsibility for their implementation where required * Assess the impact of new and updated regulatory requirements on assigned processes and areas of responsibility * Maintain strong oversight of assigned topics, ensuring processes remain compliant with relevant regulations and stakeholder expectations * Develop and maintain procedural documentation and training materials to support consistent, high-quality processes * Identify potential risks and develop strategies and solutions to contain issues, mitigate risks and drive continuous improvement * Proactively escalate significant risks and issues to the relevant Business Process Owner (BPO) and Global Process Owner (GPO) networks where necessary * Monitor service provider performance through relationship management, metrics and data analysis * Lead and support complex initiatives involving multiple stakeholders, ensuring solutions meet business and customer requirements * Work collaboratively across matrix teams, sharing knowledge and supporting colleagues to improve overall business performance * Explore opportunities to use new technologies and AI tools to develop innovative approaches to safety data transformation, maintaining appropriate human oversight