Associate Director Patient Safety Systems

Key Skills

Java Programming, Python Programming, C++, C Programming, SQL, Cloud computing, Scala Programming, Machine learning techniques, Data science techniques, MATLAB Programming, PyTorch, TensorFlow, R Programming

Job Description

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

PSSAS (Patient Safety Science, Analytics and Systems), as part of Patient Safety Center of Excellence (PS CoE), 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 PS CoE’s scientific, business and compliance needs. There are 3 openings and these can be in the USA, UK, or Sweden in our R&D Hub locations.

Reporting to the ‘Director; PS Systems’, the ‘Associate Director; Patient Safety Systems’ 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 Systems (PS Systems) 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). 

• Serves as a Subject Matter Expert (SME) within the PS Systems 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 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 of PS CoE owned information sources and toolsets. 

Required:

• Bachelor’s degree in a scientific discipline.
• Significant experience in pharmacovigilance with proven record of supporting safety tools / solutions.
• Proven competence, with extensive involvement in the successful design, delivery, validation, 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, including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, epidemiology practices, and changing safety project team activities.
• 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.

Desired:

• Higher 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