Associate Director, Patient Safety Technical Solutions

Job Description

Accountabilities Serves as a Subject Matter Expert (SME) within the PS Technical Solutions Team for reporting systems, ensuring they are capable of delivering high quality expertise and services across the PV systems estate, ensuring prioritized requirements and the strategic goals of stakeholders are understood and supported. Manages applicable tools, documentation and methodologies to ensure the reporting needs of organization are fully addressed and supported. Responsibilities of PV systems inclusive of relevant system processes, ensuring that the: System is changed in an effective and timely manner to meet new health authority requirements and / or changed business demands (e.g. divestment, in-licensing, partnership etc.). Technical components of the system are upgraded in a compliant and risk-minimized manner. Lead and coordinate routine system maintenance activities (e.g. MedDRA, WHODD, Ontology updates) System enhancement requests are identified and prioritized (change control and major change projects). Access to data is controlled, training requirements are defined and use of the system is compliant with all applicable regulations. User support arrangements (e.g. training, helpdesk) and Service Level Agreements are in place, irrespective of whether delivered internally or by external vendors / providers. Supports the ongoing business utilization of PS systems, including troubleshooting problems and developing solutions. Provides technical input and guidance on the development of strategic plans for PS systems across the enterprise. Evaluates new modules and software upgrades and assesses the impact on system validation, the user community and PV processes. Retains a global perspective around the business need for accurate, high-quality, effective and efficient information, while maintaining a focus on regulatory and corporate compliance needs. Anticipates business, regulatory and wider industry trends, and apply these in the evolution and development of safety solutions. Accountable for ensuring the quality of business-related content of relevant improvement project proposals and associated documentation in line with Company goveranance process requirements. Contributes to the development of procedures, work instructions, system specifications related to the use GPS information sources and toolsets. Participates in interactions with interal and external partners and health authorities on electronic safety data exchange. Supports the GPS as required in the license partner/CRO pharmacovigilance agreement (PVA) process. Essential Skills/Experience Bachelor s degree in a scientific discipline with relevant experience in supporting safety-related activities in clinical biopharmaceutical development. Significant experience (10+ years) in pharmacovigilance with a proven record of supporting safety tools/solutions. Proven competence in designing, delivering, deploying, or maintaining information/systems solutions in support of safety. Broad knowledge of 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. Significant experience in system validation, audit, and PV inspection activities and requirements. Excellent interpersonal and communication skills with the ability to efficiently communicate with all levels of the organization. Desirable Skills/Experience Higher degree in a clinical or safety-related discipline. Awareness of broader technological developments leveraged to inform the design and development of AZ PV Systems. Ability to identify opportunities for continuous improvement based on strong awareness of external competitive practice. Ability to lead diverse teams across multiple geographies to deliver on objectives. Experience across multiple therapeutic or business areas or in safety-related roles within other biopharmaceutical, regulatory, or health organizations. Knowledge of procedures governing clinical trial data with health authorities worldwide and experience implementing these within the business. Experience working across different geographic locations, organizations, and cultures.