Patient Safety Risk & Signal Management Product Lead

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious disease. But were more than one of the worlds leading pharmaceutical companies.

Join us as Patient Safety Risk & Signal Management Product Lead where you will play a strategic leadership role in shaping and advancing AstraZenecas global Patient Safety technology capabilities focused onSignal Management Signal Detection Benefit-Risk Evaluation and Risk Management Planning (RMP).

This role will lead the technology strategy product delivery and operational excellence for enterprise safety platforms including NGSMS and ORBIT alongside broaderpharmacovigilanceand regulatory ecosystem integrations.You will serve as a key member of the Product IT DevOps organization partnering closely with Safety Science Risk Management & Benefit-Risk teams Regulatory Affairs Safety Operations Enterprise Architecture and external technology partners to deliver scalable compliant and data-driven safety solutions supporting global regulatory obligations and proactive patient safety monitoring.

What youll do

This role requires deepexpertiseacross pharmacovigilance business processes signal management technologies risk management planning product leadership and regulated technology delivery. The ideal candidate combines strategic product thinking strong technical competence and leadership capabilities to drive modernization and innovation across the Patient Safety landscape.

Key Responsibilities:

Product Strategy & Roadmap

• Define and implement the strategic product roadmap for Risk & Signal Management platforms ensuring alignment with evolving global pharmacovigilance regulationsinspectionreadiness requirements and AstraZeneca business priorities.
• Lead technology strategy and platform evolution forNGSMSand ORBIT
• Signal Detection and Signal Validation workflows
• Benefit-Risk assessment capabilities
• Risk Management Plan (RMP) lifecycle management
• Partner with business stakeholders to translate patient safetyobjectivesinto scalable digital product capabilities.
• Drive product modernization initiativesleveragingautomation AI/ML-enabled analytics workflow orchestration and integrated safety intelligence.

Risk & Signal Management Technology Leadership

• Serve as the IT Product and Technology SME for Signal Management and Risk ManagementCapability in Platform model supportingglobal pharmacovigilance operations.
• Provide technical leadership for signal detection and triage workflowsand aggregate safety data analysis
• Health authority commitments tracking and risk minimization measure management
• Periodic safety review processes and signal governance and audit traceability
• Contribute and supportarchitectureandintegrationdiscussionsrelated to Signal and Risk Management capabilities.

Collaboration & Business Partnership

• Collaborate with cross-functional partners acrossDevelopment value streams and facilitate alignment between business process transformation initiatives.

• Act as a trusted advisor to senior leadership on Risk & Signal Management technology strategy and operational improvements.

Process Optimization & Innovation

• Identifyopportunities to streamline and automate signal management and RMP processes through digital innovation and AI-enabled capabilities.

• Drive continuous improvement initiatives across:Signal intake and prioritization; Case trend analysis Safety data visualization Risk tracking workflows

Team Leadership & Vendor Management

• Lead and mentor a team of IT professionals consultants and mentor vendor partners supporting Risk & Signal ManagementSolutions.

• Foster a culture of innovation accountability collaboration and continuous learning.

• Monitor delivery milestones SLAs deployment schedules and platform performance metrics.

Essential requirements

• BSc or MSc or equivalent experience or equivalent in information technology Life Sciences Health Sciences Computer Science ora relatedfield
• Certifications in Pharmacovigilance Agile/Product Management Cloud Technologies or IT Service Management are preferred.
• Strongexpertisein pharmacovigilance and patient safety processes including:Signal Detection and Signal management
• Benefit-Risk Assessmentand Risk Management Planning
• Knowledge of Aggregate Reportingand Safety surveillance
• Strong understanding of: ICH E2B/E2C guidelines GVP Modules FDA and EMA safety reporting regulationsand Computer System Validation (CSV) and GxPcompliance requirements
• Extensive experience with:NGSMS ORBIT
• Safety and signal management technologies

Knowledge of:

• APIs and integration frameworks

• Cloud platforms (AWS/Azure)

• Data and analytics architectures

• DevOps and CI/CD practices

• Tableau and Spotfire analytics

Desirable Skills

• Experience with AI/ML-enabled pharmacovigilance and signal analytics capabilities.

• Understanding ofclinical development processes and clinical safety data flows.

• Experience with modern cloud-native architectures and SaaS platform management.

• Familiarity with MedDRA WHO-Drug and global safety coding standards.

• Experience supporting regulatory inspections and audit readiness activities.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

We welcome your application (CV and cover letter in one document) no later than 27th July 2026!