Director, Patient Safety Technical Solutions

Job Description

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.