Associate Director, Patient Safety Technical Solutions

AstraZeneca•Wilmington, DE

About The Position

The Patient Safety Technical Solutions Team is accountable for managing the information assets and systems owned by the Chief Medical Office (CMO), ensuring they are effectively supported and governed across the enterprise as well as for deploying system analytics and informatics expertise to meet Global Patient Safety’s (GPS) scientific, business and compliance needs. Reporting to the ‘Director; PS Technical Solutions’, the ‘Associate Director; PS Technical Solutions’ provides Information reporting and technical expertise across AstraZeneca’s enterprise business-critical Patient Safety Pharmacovigilance (PV) reporting systems. The role holder works within a team of peers, all of whom employ an in-depth knowledge of business requirements, PV and regulatory policies, industry standards and trends as well as an understanding of the related assets to support effective governance, maintenance and development of the enterprise-wide systems that enable PV compliance and reporting. The role holder will work within the PS Technical Solutions Team and will directly support the design, development, implementation, continuous improvement, and/or optimal utilization of AZ Patient Safety Reporting and Reporting tool assets. They will understand how current and future components of the information and systems portfolio can be developed to ensure optimal benefit for the user community and the organization. The role has responsibility for informing and supporting the technical evolution of the PV systems and reporting estate throughout their lifecycle, ensuring they address changing external requirements and business goals (i.e. regulatory obligations, technological advancements, core business processes and information standards). The role holder will also lead the capture and development of user requirements and protect AZ’s License to Operate (LtO) by ensuring that all change is conducted in line with applicable standards (e.g. GxP requirements, systems validation, privacy, and security etc). The role has responsibility for informing and supporting the technical evolution of the PV systems estate. More specifically, this role will have the responsibility to support business by providing information by means of report creation/development from the PV systems estate ensuring that it addresses the changing external requirements and business goals throughout its lifecycle (i.e. regulatory obligations, surveillance purposes and provision of inspection required listings). The role holder will also lead the capture and development of user requirements and protect AZ’s License to Operate (LtO) by ensuring that all reporting requirements and associated changes are conducted in line with applicable standards (e.g. GxP requirements, systems and reporting validation, privacy, and security etc).

Requirements

Bachelor’s degree in a scientific; IT; or numerate discipline, with relevant experience in supporting reporting related activities in the context of patient data.
Extensive experience (5+ years) in an Analytics/Business intelligence/Reporting role with proven experience of requirements gathering and delivery of reporting solutions
Proven competence, with extensive involvement in the successful design, delivery, deployment, or maintenance of validated MIS reporting solutions in support of patient safety.
Broad knowledge of reporting tools and practices such as (but not limited to) Oracle Analytics/OBIEE, Business Objects; COGNOS etc.
Strong SQL querying knowledge.
Broad knowledge of data visualisation techniques.
Ability to articulate complex safety-related business needs in the context of Report design, architecture, and development.
Extensive experience in system validation, audit and PV inspection activities and requirements.
Experience in working across different geographic locations, organizations, and cultures.
Excellent interpersonal and communication skills with the ability to efficiently communicate with all levels of the organization.
Ability to prioritise work and deliver accurate results in a timely fashion in fast paced environment to multiple stakeholders.

Nice To Haves

Advanced degree in a clinical or safety-related discipline.
Awareness of broader technological developments both internally and externally leveraged to inform the design and development of AZ PV Systems.
Able to identify opportunities to lead change through continuous improvement based on strong awareness of external competitive practice.
Ability to lead diverse teams across multiple geographies to deliver on objectives (Leadership Capabilities)
Experience across multiple therapeutic or business areas, or in working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.
Knowledge of the procedures, processes and standards governing clinical trial data (documents and data) with health authorities worldwide, and experience of implementing these within the business.

Responsibilities

Serves as a Subject Matter Expert (SME) within the PS Technical Solutions Team for reporting systems, ensuring they can deliver 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 the organization are fully addressed and supported.
Responsibilities of Technical Solutions inclusive of relevant system processes, ensuring that the: Patient Safety PV reports are developed in line with regulatory requirements or business demands and are maintained and validated to GvP practices Reporting systems are 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 reporting systems are upgraded in a compliant and risk-minimized manner. 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 reporting, including troubleshooting problems and developing new reporting 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 reporting solutions.
Accountable for ensuring the quality of business-related reporting content of relevant improvement project proposals and associated documentation in line with Company governance process requirements.
Contributes to the development of procedures, work instructions, system specifications related to the use of PS CoE owned information sources and toolsets.
Participates in interactions with internal and external partners and health authorities on electronic safety data exchange.
Supports the PS CMO as required in the license partner/CRO pharmacovigilance agreement (PVA) process.