Safety Data Transformation Lead

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

• 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