Role: Safety Data Transformation Lead / Specialist
Location: Welwyn (Hybrid – hybrid working with 2 days per week in the office)
Hours: Full-time
Pay: £29.85-£35.82 PAYE basic or £40-£48 UMB / LTD
Contract: Until the end of December 2027 – Outside IR35

An excellent opportunity has arisen for a Safety Data Transformation Lead / Specialist to join one of our longstanding clients, an established organisation within the pharmaceutical and healthcare sector.

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.

The Requirements:

• 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

The Role:

• 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

If you’re keen to join an innovative organisation and use your pharmacovigilance expertise to drive safety data transformation, improve processes and ultimately support patient safety, then please apply for this Safety Data Transformation Lead / Specialist role below or call Chloe McCausland at Clearline Recruitment on 01273 063769 between 8:30am – 5:00pm.