Working with Compliance Lead in the QPPV&PV Excellence Team in Patient Safety Centre of Excellence, in Chief Medical Office (CMO), taking responsibility for the management of assigned AstraZeneca projects and partnerships including: quality and compliance monitoring, data analytics to identify root causes and continuous improvement.  Accountable to develop relationships across CMO and other relevant AZ functions, to execute the delivery of the QPPV&PV Excellence continuous improvement strategy and priorities.

Responsibilities:

• Promote a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches, across the AZ Pharmacovigilance (PV) system.
• Provides analytical support for Pharmacovigilance Compliance Systems.
• Provides expertise and resource for the design, development, implementation and continuous improvement, of a global portfolio of compliance analytics/reports.
• Supports the existing portfolio of reports/dashboards across various technical platforms (Spotfire, Oracle APEX, Excel VBA), providing continuous improvement and customer support.
• Provides analytical input where required to KPIs, internal and external benchmarks, compliance and data quality issues, as well as responding to ad hoc business requirements, including requests in support of regulatory inspections.
• Acts as a key interface to customer groups and process area leads, both within and outside of Patient Safety (e.g. Operations), to understand reporting/analytical requirements and to develop solutions to meet those requirements.
• Provides data modelling support, specifically with a view to integrating data across Pharmacovigilance Systems
• Working with Patient Safety Process and Partnerships Leads and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global  KPIs related to pharmacovigilance data reporting.
• Develop and improve reporting tools and analysis processes and technology.
• Manage relationships/partnerships/alliances external to the CMO function that are essential to delivering AstraZeneca’s pharmacovigilance License To Operate responsibilities, e.g. with AstraZeneca affiliates.
• Working collaboratively, provide expertise and sharing best practices across all regions and in all partnerships.
• Seek personal and professional development opportunities and share knowledge gained in open forums.
• Ensure that appropriate, up-to-date records are maintained for compliance.

Essential

• Bachelor’s/Master’s degree or equivalent qualification in scientific or computer science discipline
• At least 2 years’ experience working within a regulatory environment with an understanding of regulatory processes and systems
• Proven analytical ability to interpret and integrate complex data sets and communicate them effectively.
• Strong desire to move into a technical data/analytics role
• Awareness of wider IS developments within AZ or the pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions, data integration systems and practices, etc.
• Able to work independently to solve complex problems, often while working with uncertain assumptions.
• Highly developed conceptual and analytical thinking, with ability to understand multiple, complex business needs.

Desirable ​

• At least 2 years Regulatory, Patient Safety or broader pharmaceutical industry experience, including involvement in the successful design, delivery or deployment of information/systems solutions to meet business needs.
• Technical skills in the following areas – Excel (incl. VBA), SQL, Python, R, visual analytics (Tibco Spotfire or similar)
• Competence in the development of tools and methods to exploit data in support of business decision making including data modelling, data integration (ETL)
• Key capability requirements:
  • Ability to manage multiple stakeholders
  • Solution focused
  • Excellent influencing, negotiation and communication skills
• Ability to quickly acquire and assimilate knowledge across different disciplines and business areas.
• Knowledge of QMS and continuous improvement methodologies

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.