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: continuous improvement; communication; performance monitoring; quality and compliance.  Accountable to develop relationships across CMO and other relevant AZ functions, to execute the delivery of the QPPV&PV Excellence strategy and priorities.

Responsibilities:

• Promote a culture of continuous improvement, high performance, flexibility and quality emphasizing a “can do” attitude and innovative approach.
• Identify opportunities to improve and simplify the methodology in quality and compliance related processes.
• 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, analysis processes and technology.
• Monitor periodic compliance data.
• Contribute to analysis and trending.
• Identify issues and risks and propose options to mitigate them.
• Utilise knowledge of pharmacovigilance and associated regulatory and drug development processes to maintain and support the global inspection readiness strategy.
• Provide support to outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintain inspection readiness.
• 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.
• Deliver on project assignments supporting the business, e.g. representation on global cross-functional task forces.
• 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

• A science/pharmacy/nursing degree, with at least 2 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Experience in working cross-functionally and across cultures
• Leadership skills, including project management experience
• Knowledge of the drug development process
• Good attention to detail
• Excellent written and verbal communication skills
• Strong collaboration skills
• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours
• Good time management
• Fluent in English
• Computer literate

Desirable

• MSC/PhD in scientific discipline
• Knowledge of new and developing regulatory and pharmacovigilance expectations
• Knowledge of existing AstraZeneca external alliances and collaborative projects
• Experience of working in a global organisation, preferably within the pharmaceuticals industry
• Knowledge of ICSR case handling
• Good technology skills and experience in data analytics
• Ability to lead change without authority

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.