AtAstraZenecawe turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
Information Strategy & Systems Analytics, Senior Scientist
- Provide product, process, and scientific knowledge to ensure that health and safety information is effectively evaluated in the most efficient manner, and that this information remains aligned with strategic direction across the business.
- Evaluate AstraZeneca systems for compliance with corporate and government standards and regulations.
- Manage applicable tools and methodologies to ensure existing processes and systems fully address the needs of the stakeholders, and identify opportunities where innovative health and safety solutions and plans should be better aligned with best practice across the industry.
- Provide input on the development of strategic and tactical plans for technical regulatory and safety knowledge to stakeholders and project teams.
- Understand stakeholder needs and translate business needs into business requirements, in order to address future information and health and safety systems solutions in support of necessary pharmacovigilance capabilities.
- Retain a global perspective of the business need for accurate, high-quality, effective and efficient information and systems resources, with a focus on pharmacovigilance and corporate compliance needs.
- Anticipate business, regulatory, and pharmaceutical industry trends, and apply these trends in the development of patient safety solution programs, in order for clinical teams to better enforce laws and regulations governing the health and safety of individuals, and comply with corporate health and safety standards.
- Accountable for ensuring the quality of business-related content of relevant improvement project proposals and associated documentation, in line with company governance process requirements.
- Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
- Maintain knowledge of the company's disease and therapeutic areas for marketed drugs and drugs in development.
- Conduct User Acceptance Testing ("UAT") on validated systems and databases, to ensure effective program and vendor management on timely deliverables and resource requirements are aligned with standard operating procedures and policies.
- Must have two (2) years of experience with: Oracle; Java; Sharepoint Online; HTML; MS Suite; MS Project; Citrix; SQL; SAP Business Objects; pharmacovigilance regulations, including ICSR reporting, Periodic Reporting, Global Data Privacy Regulations, Electronic Records, Electronic Signature, Audit Trail, Good Pharmacovigilance Practices, and Compliance; managing off-shore vendors by tracking progress of activity in Jira and Service NOW; resolving issues, bugs, and system enhancements; conducting project management for a multi-phased global projects including deliverable dates and resource management; Conducting risk-minimization strategies and global business support of Pharmacovigilance systems using Sapphire and Jasper; training users on system utilization and features; GxP documentation; defining business requirements utilizing iterative and Agile approach; preparing and reviewing Requests for Information ("RFIs") and Requests for Proposals ("RFPs"); conducting User Acceptance Testing ("UAT"), Operational Qualification ("OQ"), and Regression Testing; meeting health authority requirements and timelines, including 21 C.F.R. regulations; creating and executing testing within validated systems; translating business requirements into system requirements for technical resolution within applications and databases for enterprise-wide Pharmacovigilance support; Good Manufacturing Practice ("GMP"); Good Clinical Practice ("GCP"); and Regulatory Standard Operating Procedures ("SOP"). EOE.
- Position requires Master's degree or foreign equivalent in Information Technology, Pharmaceutical Science, Biology or a related field, plus two (2) years of experience as a Patient Safety Specialist, Patient Safety Scientist, or related.
- Employer will accept pre- or post-Master's degree experience.