Patient Safety Risk & Signal Management Product Lead

Description

The company is a science-led biopharmaceutical business that discovers, develops and commercialises prescription medicines for some of the world's most serious diseases.

As Associate Director, Patient Safety Risk & Signal Management Product Lead, you will set the direction for the company's global Patient Safety technology in signal management, signal detection, benefit-risk evaluation and Risk Management Planning (RMP).

You will own the technology strategy, product delivery and operational performance of enterprise safety platforms, including NGSMS and ORBIT, and their links to wider pharmacovigilance and regulatory systems.

You will sit in the Product IT DevOps organisation and work with Safety Science, Risk Management & Benefit-Risk, Regulatory Affairs, Safety Operations, Enterprise Architecture and external technology partners. The aim is safety solutions that are scalable, compliant, data-driven and support global regulatory obligations and proactive patient safety monitoring.

Responsibilities

• Write and deliver the product roadmap for risk and signal management platforms, keeping it aligned with changing global pharmacovigilance rules, inspection readiness needs and company business priorities.
• Lead technology strategy and platform change for NGSMS and ORBIT.
• Own the product direction for signal detection and validation, benefit-risk assessment, and RMP lifecycle management.
• Work with business stakeholders to turn patient safety goals into scalable digital product capabilities.
• Drive modernisation using automation, AI and ML analytics, workflow orchestration and joined-up safety intelligence.
• Act as the IT product and technology subject matter expert for signal and risk management across the platform model that supports global pharmacovigilance operations.
• Lead technical direction for signal detection, triage workflows and aggregate safety data analysis.
• Track health authority commitments and manage risk minimisation measures.
• Oversee periodic safety review processes, signal governance and audit traceability.
• Contribute to architecture and integration decisions for signal and risk management capabilities.
• Work with cross-functional partners across development value streams to align business process change.
• Advise senior leaders on risk and signal management technology strategy and operational improvements.
• Find ways to streamline and automate signal management and RMP work using digital and AI-enabled tools.
• Lead continuous improvement across signal intake and prioritisation, case trend analysis, safety data visualisation and risk tracking workflows.
• Lead and mentor IT staff, consultants and vendor partners who support risk and signal management solutions.
• Build a culture of innovation, accountability, collaboration and continuous learning.
• Monitor delivery milestones, SLAs, deployment schedules and platform performance metrics.

Requirements

• Essential: a BSc or MSc, or equivalent experience, in information technology, life sciences, health sciences, computer science or a related field.
• Essential: strong experience in pharmacovigilance and patient safety, especially safety signal detection and patient safety risk management.
• Essential: strong experience in signal detection, signal management, benefit-risk assessment, risk management planning, and aggregate reporting and safety surveillance.
• Essential: solid knowledge of ICH E2B and E2C guidelines, GVP modules, FDA and EMA safety reporting rules, computer system validation and GxP compliance.
• Essential: extensive hands-on experience with NGSMS and ORBIT, and with safety and signal management technologies.
• Essential: working knowledge of APIs and integration frameworks, cloud platforms (AWS or Azure), data and analytics architectures, DevOps and CI/CD practices, and Tableau and Spotfire.
• Preferred: certifications in pharmacovigilance, Agile or product management, cloud technologies, or IT service management.
• Desirable: experience with AI or ML-enabled pharmacovigilance and signal analytics.
• Desirable: understanding of clinical development processes and clinical safety data flows.
• Desirable: experience with modern cloud-native architectures and SaaS platform management.
• Desirable: familiarity with MedDRA, WHO-Drug and global safety coding standards.
• Desirable: experience supporting regulatory inspections and audit readiness work.

Conditions

You will be in the office at least three days per week, with some flexibility for individual needs.

Applications close on 15 November 2026. Send your CV and cover letter as one document.

The company welcomes applications from all qualified candidates and offers reasonable adjustments during the process; request these in the application form.