Patient Safety Risk & Signal Management Product Lead

AstraZeneca; Göteborgs kommun; Hybrid; SEK 900,000 - 1,500,000; Full time

Job summary

AstraZeneca is seeking an Associate Director - Patient Safety Risk & Signal Management Product Lead to shape global safety technology capabilities and lead strategy for NGSMS and ORBIT.

You will drive product delivery, compliance, and modernization, partnering with Safety Science, Regulatory Affairs and external partners to enable data-driven pharmacovigilance.

This hybrid role blends strategic leadership with hands-on delivery in a world-class biopharma environment.

Qualifications

• Deep expertise in pharmacovigilance processes, signal management and risk management planning.
• Experience leading technology-driven product delivery and modernization.
• Ability to work with regulatory affairs and global stakeholders.

Responsibilities

• Define and implement the strategic roadmap for Risk & Signal Management platforms.
• Lead technology strategy and platform evolution for NGSMS and ORBIT.
• Drive signal detection, triage workflows and safety data analysis.
• Collaborate with cross-functional partners to translate safety objectives into scalable capabilities.
• Mentor IT professionals and manage vendor partners to ensure on-time delivery.

Skills

Pharmacovigilance

Product leadership

Technology strategy

Cross-functional

Tools

NGSMS

ORBIT

Safety IT systems

Job description

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.

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.

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.

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.