Astrazeneca AB jobb

Job Title: Senior Director Physician, Cardiovascular Safety Knowledge Group Expert, AZ ECG Centre Cardiologist Are you ready to lead the science of cardiovascular safety at global scale and translate digital cardiac insights into safer medicines for patients? Can you see yourself steering complex trials, guiding safety signals from early development through late-stage decision points, while mentoring experts and shaping strategy? In this dual role, you will serve as a Cardiologist in the AZ ECG Centre and as a Cardiovascular Safety Knowledge Group Expert. You will drive the design and delivery of ECG core laboratory services, elevate clinical decision-making across programs, and set the standard for detection, diagnosis, and mitigation of drug- and biologic-induced cardiovascular toxicity. Your work will influence molecule development across multiple portfolios and therapeutic areas, ensuring our breakthroughs reach patients with uncompromising safety and scientific rigor. You will partner closely with clinical development, global patient safety, biometrics, and regulatory teams to define best practices in cardiovascular safety, build and validate new digital and biomarker methodologies, and engage with governance and regulatory bodies. The impact is immediate and far-reaching: faster, more confident decisions in trials and a stronger cardiovascular safety framework across our pipeline. Accountabilities Deliver high-quality cardiology and scientific oversight for ECG core lab activities, including digital ECG data review and interpretation; provide second opinions on ECG/arrhythmia/vital signs and other cardiovascular findings to project teams and investigators to enable clear, timely clinical decisions. Author and review study synopses, clinical study protocols, statistical analysis plans and outputs, and clinical study reports to ensure robust cardiovascular endpoints, endpoints quality, and regulatory-ready documentation. Act as the cardiovascular safety expert for design, conduct, monitoring, data interpretation, and reporting of potential clinical safety signals; connect signal detection to actionable study and program strategies. Manage global research projects that advance state-of-the-art detection, management, and mitigation of drug- and biologic-induced cardiovascular toxicities; ensure adherence to Good Clinical Practice and global regulatory requirements. Provide expert contributions to the development, testing, and validation of new methodologies for ECG and Holter analysis and blood pressure recording; evaluate and guide the applicability of connected cardiovascular devices and wearables in clinical trials to enhance data quality and patient insight. Advise on cardiovascular imaging techniques and cardiac safety biomarkers to optimize safety monitoring and prevent toxicity across studies. Provide scientific and medical input to global patient safety activities with a focus on cross-project and cross-TA initiatives; promote safety sciences and clinical safety practices across programs and therapeutic areas; contribute to the evolution of the functional strategy and the global clinical safety working model. Regulatory and External Engagement: Support interactions with internal governance and international regulatory bodies; contribute to regulatory strategy and responses that strengthen cardiovascular safety profiles. Biomarker Development and Translation: Lead cardiovascular toxicity biomarker development projects and partner with preclinical leaders to align translational strategies that anticipate and mitigate patient risk. Essential Skills/Experience Medical practitioner (medical degree) with at least 5 years drug development experience Specialty training and board certification in the field of expertise Recognized by peers for therapeutic area expertise and commercial/safety understanding Regulatory Agency interactions experience (authoring briefing documents / regulatory responses / label discussions) Leading cross-functional teams Broad knowledge of drug development and global regulatory requirements with regards to cardiovascular-specific safety evaluation, safety reporting and risk management strategies Influencing skills, excellent verbal and written communication skills Capable of conceptual thinking and strategic vision with respect to cardiovascular toxicity Ability to identify and mitigate against cardiovascular toxicity risks Ability to establish causality in cases of CV injury Ability to define best practices in CV safety Desirable Experience At least 2 years of patient safety experience Experience in setting up internal and external collaborations (e.g. safety consortia) to promote organ safety Academic / research experience in kidney injury Demonstrated experience in adopting new technology (biomarkers, etc.) Strategic thinking and influencing with respect to CV safety Demonstrated capability to lead implementation of new technology and/or working routines within a complex organization. Strong team-working skills and an ability to work collaboratively in a global pharmaceutical environment Why AstraZeneca Join a global, science-led enterprise that turns cutting-edge research into medicines for complex diseases at speed and scale. You will work at the intersection of digital cardiovascular science, patient safety, and translational medicine, surrounded by teams that connect diverse perspectives to solve high-stakes problems. Here, your expertise will shape a rapidly advancing pipeline, influence regulatory strategy, and strengthen how we protect patients worldwide. We value ambition alongside kindness, pair bold ideas with disciplined execution, and equip you with advanced tools and collaborative networks so you can push boundaries and see your impact in real clinical outcomes. Lead the future of cardiovascular safety and help bring safer, life-changing medicines to patients—take your next step with us today. Welcome with your application!

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!