Modis Life Science is now looking for a Compliance Principal / Compliance Analyst for a consultancy assignment at AstraZeneca in Gothenburg. The assignment will start in December and initially run for 6 months. If you find the role interesting send your application asap, no later than November 18th.
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.
- Drive 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 tools and reports.
- Supports the existing portfolio of reports/dashboards across various technical platforms (Spotfire, Oracle APEX, Excel VBA), further developing them and providing 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.
- Leads and/or contributes to specific projects/workstreams as required, to ensure full exploitation of compliance data.
- 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 technical 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.
- 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.
Education, Qualifications, Skills and Experience:
The following is highlighted:
- Technical skills in the following areas – Excel (incl. VBA), SQL, Python, visual analytics (Tibco Spotfire or similar)
- Proven competence in the development of tools and methods to exploit data in support of business decision making including data modelling, data integration (ETL)
- 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.
- Bachelor´s/Master´s degree or equivalent qualification in computer science or scientific discipline
- Experience working within a regulatory environment with an understanding of regulatory processes and systems
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