Compliance Principal / Compliance Analyst

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:
•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.

DESIRED QUALIFICATIONS:
•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.

DESIRED BACKGROUND:
•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

ABOUT ALTEN
ALTEN is a consulting company that develops and delivers expertise for world-leading companies with consultants in technology, IT and biochemistry. We are located in over 28 countries, have our headquarter in Paris and have more than 37 200 employees, of which 88 percent are engineers. In Sweden, we have over 1 700 employees and work from offices in twelve locations. Our clients are found in industries such as Automotive, Energy, Telecom, Industry, Aerospace & Defense and Life Science, where our consultants operate throughout the product development chain.

Welcome to read more about us at alten.se or please contact Oscar Sundell, Business Manager at Oscar.Sundell@alten.se.