Associate Director, Patient Safety Technical Solutions

Job Title: Associate Director, Patient Safety Technical Solutions

Location: Wilmington, DE

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). 

Typical Accountabilities:

• 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 con