Patient Safety Risk & Signal Management Product Lead
AstraZeneca
Sweden - GothenburgPosted Discovered via the company's careers siteMatch locked
Full time
About the role
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. But we're more than one of the world's leading pharmaceutical companies.
Role Overview
Join us as
Associate Director - 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.
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
- Strong expertise in pharmacovigilance and patient safety processes with focus on safety signals Detection and patient safety risk management
- 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.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's 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.
Why AstraZeneca?
At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's 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. We're on an exciting journey to pioneer the future of healthcare.
What is next?
We welcome your application (CV and cover letter in one document) no later than 15 November 2026 .
Date Posted
27-Oct-2026
Closing Date
15-Nov-2026
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Not included in the source posting: qualifications, benefits.
Skills
artificial-intelligencedevopsmachine-learningagileawsazureci-cdproduct-managementtableau
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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