Director, Patient Safety Technical Solutions

Accountabilities:

• Supervise a team within the Patient Safety Technical Solutions organization, ensuring high-quality expertise and services across the pharmacovigilance compliance systems estate.
• Drive a performance-focused culture within the team by supporting ongoing development of expertise, leadership, and talent.
• Provide global expertise in respect of the Company’s core pharmacovigilance compliance systems.
• Lead applicable tools and methodologies to ensure processes and systems fully address stakeholder needs.
• Ensure system ownership of PS systems, inclusive of relevant system processes.
• Support ongoing business utilization of PS systems, including troubleshooting problems and developing solutions.
• Provide technical guidance on the development of strategic plans for PS systems across the enterprise.
• Evaluate new modules and software upgrades and assess their impact on system validation, user community, and PV processes.
• Ensure compliance with global and local procedural documents and local implementation of Global Patient Safety objectives, policies, processes, and procedures.
• Participate in interactions with licensing partners and health authorities on electronic safety data exchange.
• Support as required in the license partner/CRO pharmacovigilance agreement (PVA) process.
• Manage team resources and deliver effective service to Global Patient Safety and the enterprise.
• Proactively manage supply/demand forecasts for their area and prioritize workload to meet business demand.

Essential Skills/Experience:

• Bachelor’s degree in a scientific field, with relevant experience in supporting safety-related activities in the context of clinical biopharmaceutical development.
• Significant experience (12+ years) in pharmacovigilance with a proven record of supporting safety tools/solutions.
• Proven competence with extensive involvement in the successful design, delivery, deployment, or maintenance of information/systems solutions in support of safety.
• Broad knowledge of the safety information tools required to support drug development and marketed brands within AstraZeneca.
• Ability to articulate complex safety-related business needs in the context of IS systems design, architecture, and development.
• Business awareness of wider IS developments within AZ or the pharmaceutical industry.
• Significant experience in system validation, audit, and PV inspection activities and requirements.

Desirable Skills/Experience:

• Higher degree or equivalent experience in a clinical or safety-related field.
• Demonstrable leadership skills with experience in line-managing diverse groups of experts.
• Key capabilities commensurate with the Global Career Level of the role (e.g., Leadership Capabilities).
• Ability to find opportunities to lead change through continuous improvement based on strong awareness of external competitive practice.
• Experience across multiple therapeutic or business areas or working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.
• Knowledge of procedures, processes, and standards governing clinical trial data with health authorities worldwide.
• Excellent interpersonal skills to influence/shape their team and understand multiple complex business needs.

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. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Join us on our journey to create the future of medicine as we work towards our ambition to become a healthcare provider beyond medicines. A place to be truly patient-centric, we use technologies to better understand diseases, develop new medicines and support patients with all aspects of their disease. It means new ways of working, new technologies and new ways to interact with patients. Be part of making the entire Research & Development cycle digitally-enabled: improving clinical trials and data collection, digital therapeutics for rapid diagnostics, wearables, machine learning and visual analytics for informed decision-making, integrated data to improve patient outcomes, and insights to inform the next generation of products. Be empowered to act; here you can explore and disrupt whilst working on the forefront. It takes a can-do, positive and resilient attitude, often overcoming setbacks as we evolve and innovate at the same time. If you thrive on adapting your skills and learning from failures, then this is the place for you. Research & Development is at the heart of AstraZeneca. Take our pipeline to the next level using the latest technologies and backed by our ethos to follow the science. Help to lead a changing industry as we work at the forefront and partner across the healthcare ecosystem.

Ready to make a difference? Apply now!

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.