Patient Safety IT Product Lead
Role Overview:
As the Patient Safety IT Product Lead, you will play a critical role in managing and enhancing the suite of pharmacovigilance and safety reporting technologies, including Oracle Argus, Aris global Signal Management, and other pharmacovigilance platforms used at AstraZeneca. You will be a key member of the Product IT DevOps team, driving the technology strategy and delivery of IT solutions working with scaled delivery platform team that support global patient safety and regulatory reporting requirements.
You will collaborate closely with IT Platform Lead, Business Product Managers, Solution Architects, and key stakeholders to ensure that technology solutions are aligned with business goals, regulatory compliance, and industry best practices. This role requires a hybrid skill set of technical expertise, business domain knowledge, and leadership capabilities to deliver high-value results in a complex, regulated environment.
Key Responsibilities:
Product Strategy & Roadmap: Develop and maintain a strategic product roadmap for safety reporting and pharmacovigilance platforms, ensuring alignment with regulatory requirements and business objectives. Cultivate and demonstrate an in-depth knowledge of drug development business capabilities focused on patient safety.
Technical Leadership: Provide technical oversight and guidance for the implementation and integration of Oracle Argus, AE Intake systems, Literature Management, Signal Management, Reporting (including aggregate reporting), and Analytics (Tableau, Spotfire). Lead system design and architecture discussions to support efficient, scalable, and compliant solutions.
Stakeholder Collaboration: Engage with cross-functional teams, including Safety Operations, Regulatory Affairs, IT, and external vendors, to define requirements and deliver solutions that support safety reporting and signal detection processes.
Solution Delivery & Support: Oversee the end-to-end delivery of IT solutions, including configuration, customization, testing, and deployment. Ensure robust system validation and compliance with GxP, FDA, and EMA guidelines. Leverage Confluence and JIRA to execute Pharmacovigilance DevOps projects.
Process Improvement & Innovation: Identify opportunities to optimize and automate safety reporting processes through technology enhancements, ensuring continuous improvement and operational excellence. Develop strategies for product design, engineering, platforms, data architecture, and analytics.
Team Leadership & Mentoring: Lead, coach, and mentor a team of IT professionals, fostering a collaborative and innovative environment to achieve business and technology goals. Manage a group of consultants for delivery and sustainment, ensuring the quality of deliverables and monitoring service levels and deployment schedules.
Cloud & Database Management: Oversee database management, system analysis, design, and disaster recovery plans. Experience with cloud platforms, such as AWS, is highly desired, including relevant cloud certifications.
Role-Specific Activities:
Safety Technology Expertise: Serve as the IT Subject Matter Expert (SME) for safety reporting and signal management technologies, providing strategic guidance and technical support for pharmacovigilance operations.
Regulatory Compliance: Ensure all IT systems and processes comply with global regulatory requirements for safety reporting, including GVP, GxP, FDA, EMA, and ICH guidelines.
Platform Integration: Lead the integration of safety systems with other clinical and regulatory platforms, such as EDC (Electronic Data Capture), Clinical Data Repositories, and Regulatory Submission Systems.
Vendor Management: Collaborate with technology vendors to drive enhancements and ensure the delivery of high-quality solutions that meet business needs.
Change Management: Develop and implement change management strategies to support the adoption of new systems and processes, ensuring minimal disruption to business operations.
Agile & DevOps Practices: Utilize Agile and Scrum methodologies to deliver high-quality, timely solutions. Lead DevOps practices within the pharmacovigilance domain, ensuring a robust continuous integration/continuous delivery (CI/CD) pipeline and effective collaboration between development and operations teams.
Essential Skills & Experience:
Educational Background: Bachelor’s or Master’s degree in health sciences, Information Technology, or a related field. Certifications in pharmacovigilance, IT management, or cloud platforms are a plus.
Technical Proficiency:
Extensive experience with Oracle Argus and Aris global Signal Management platforms, as well as other pharmacovigilance systems such as AE Intake, Literature Management, and Reporting tools.
Strong understanding of pharmacovigilance processes, including adverse event reporting, signal detection, and risk management.
Strong understanding of The E2B and E2C guidelines are part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations.
Experience with analytics tools such as Tableau and Spotfire.
Experience with integration technologies (APIs, ETL tools) and cloud platforms (AWS, Azure).
Knowledge of Computer System Validation (CSV) and experience working in a GxP-regulated environment.
Leadership Experience: Proven track record in leading IT product teams, managing complex projects, and delivering solutions in a regulated environment.
Delivery & Execution: Strong delivery skills with the ability to work in a complex environment and influence cross-functional teams. Experience managing SaaS applications, service levels, and deployment schedules.
Analytical & Problem-Solving Skills: Ability to assess complex business and technical challenges, propose innovative solutions, and drive implementation.
Communication & Stakeholder Management: Strong communication skills, with the ability to engage and influence senior stakeholders and cross-functional teams. Adept at bridging the gap between business and IT to drive alignment and successful outcomes.
Desirable Skills:
Experience with other pharmacovigilance and clinical safety platforms, such as Argus, ARISg, Emiprica, Veeva Vault Safety, MedDRA, WHO-Drug, and HL7/FHIR standards.
Understanding of clinical trial processes and their impact on safety data management.
Experience in Agile methodologies and DevOps practices, including JIRA and Confluence.
Cloud certifications (AWS, Azure) and experience with cloud-native architectures.
WHY JOIN US?
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.
Help to shape our journey towards becoming a tech-enabled enterprise. Encouraged to look to the future, think strategically and innovate, we influence progress today. We are constantly introducing new solutions and technology through on our quest to grow through innovation. We love it here because put simply, we make a meaningful impact.
Technology at AstraZeneca is a home for purposeful disruptors. Apply now to learn more about this exciting opportunity with a world-renowned pharmaceutical brand!
SO, WHAT’S NEXT?
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
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Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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