Associate Director, Patient Safety Technical Solutions

Job Title: Associate Director, Patient Safety Technical Solutions

Global Career Level: E

Introduction to role

The Patient Safety Technical Solutions Team as a part of the wider Patient Safety Operations, Technology and Analytics Team (OTA) 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.

Reporting to the ‘Director; PS Technical Solutions’, the ‘Associate Director; Patient Safety Technical Solutions’ provides Pharmacovigilance (PV) subject matter and technical expertise across AstraZeneca’s enterprise business-critical PV 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 Patient Safety Technical Solutions Team and will directly support the design, development, implementation, continuous improvement, and/or optimal utilization of AZ safety systems and assets.  He / She 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 specific responsibility for informing and supporting the technical evolution of the PV systems estate throughout its lifecycle, ensuring it addresses 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). 

Accountabilities

• Serves as a Subject Matter Expert (SME) within the Patient Safety Technical Solutions Team, ensuring it is 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 processes and systems fully address the needs of organization.

• Responsible for maintaining and evolving PV technology inclusive of relevant system processes, ensuring that the: 

  • Technology 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 technology, including troubleshooting problems and developing solutions.  

• Provides technical input and guidance on the development of strategic plans for PS technology 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 of Patient Safety Technical Solutions owned information sources and toolsets. 

Essential Skills/Experience

• Bachelor’s degree in a scientific discipline.

• 10+ years of relevant experience.

• Proven competence, with extensive involvement in the successful design, delivery, validation, deployment or maintenance of information/systems solutions in support of safety.

• Ability to articulate complex safety-related business needs in the context of IS systems design, architecture and development.

• Experience in working across different geographic locations, organizations, and cultures.

• Excellent interpersonal and communication skills with ability to efficiently communicate with all levels of the organization.

• Strong knowledge on the below Technologies – Python, Oracle Apex, Power BI, Power Automate, SharePoint Online. 

Desirable Skills/Experience

• Higher degree in a clinical or safety-related discipline.

• Significant experience in pharmacovigilance with proven record of supporting safety tools / solutions.

• Broad knowledge of the safety information tools required to support drug development and marketed brands within AstraZeneca, including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, epidemiology practices, and changing safety project team activities.

• 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.

Key Relationships to reach solutions

Internal (to AZ or team)

• Head of GPS

• PS Therapeudic Area (TA) partners

• Information Technology partners

• Data Science Teams

• Other key science unit stakeholders across the enterprise

External (to AZ)

• External regulatory authorities and industry/authority groups

• Licensing Partners

• External consultancy and/or staffing agencies

• IS/IT partners and vendors

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.

At AstraZeneca, we are driven by a shared vision to transform the way cancer is treated. Our commitment to science and innovation is unwavering, as we strive to make a meaningful impact on patients' lives. With one of the broadest Oncology pipelines in the industry, we offer unparalleled opportunities for growth and collaboration. Our supportive and diverse teams empower each other to take smart risks, challenge norms, and learn from every experience. Together, we are resilient and optimistic, working towards a future where cancer is no longer a cause of death.

Ready to join us on this exciting journey? Apply now and be part of a team that's making a difference!

Date Posted

Closing Date

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.