Arbetsbeskrivning

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 world's most serious disease.

Role

Join us as Patient Safety Risk & Signal Management Product Lead, where you will play a strategic leadership role in shaping and advancing AstraZeneca's global Patient Safety technology capabilities focused on Signal 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 broader pharmacovigilance and 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 you'll do

This role requires deep expertise across 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 regulations, inspection readiness requirements, and AstraZeneca business priorities.
• Lead technology strategy and platform evolution for NGSMS and ORBIT
• Signal Detection and Signal Validation workflows
• Benefit-Risk assessment capabilities
• Risk Management Plan (RMP) lifecycle management
• Partner with business stakeholders to translate patient safety objectives into scalable digital product capabilities.
• Drive product modernization initiatives leveraging automation, 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 Management Capability in Platform model supporting global pharmacovigilance operations.
• Provide technical leadership for signal detection and triage workflows and 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 support architecture and integration discussions related to Signal and Risk Management capabilities.

Collaboration & Business Partnership

• Collaborate with cross-functional partners across Development 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

• Identify opportunities 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 Management Solutions.
• 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, or a related field
• Certifications in Pharmacovigilance, Agile/Product Management, Cloud Technologies, or IT Service Management are preferred.
• Strong expertise in pharmacovigilance and patient safety processes including: Signal Detection and Signal management
• Benefit-Risk Assessment and Risk Management Planning
• Knowledge of Aggregate Reporting and Safety surveillance
• Strong understanding of: ICH E2B/E2C guidelines, GVP Modules, FDA and EMA safety reporting regulations, and Computer System Validation (CSV), and GxP compliance 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 of clinical 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.

Apply no later than 7th June, 2026!