Job Description

Introduction to role Join our dynamic team as an Associate Director, Pharmacovigilance Processes, where you will work closely with the PV Processes Manager, Associate Director, and Director. You will be responsible for handling assigned AstraZeneca projects and processes, including implementation, communication, compliance, performance, and inspection readiness. You will develop relationships across Patient Safety and other relevant areas of AstraZeneca to complete the delivery of the processes strategy and priorities, alongside governance and management of current procedural documents. Accountabilities Find opportunities for and drive the enhancement of existing processes through knowledge of internal and external environments. Work with Process Managers, Associate Directors, Patient Safety, and Regulatory authorities to develop, establish, monitor, report, and assess global KPIs related to safety and regulatory data reporting. Lead the management of process updates in Patient Safety; initiate updates, project manage the delivery of new documents, work with the BPO for content updates, address comments, and release the document. Be an expert in the ECMS tool and associated processes. Support PS Process owners with guidance, advice, and support on PD processes. Use safety and regulatory knowledge to maintain and support the global inspection readiness strategy. Provide process or compliance support to regulatory teams and submissions using a deep understanding of pharmacovigilance processes and regulations. Establish a culture of continuous improvement, high performance, flexibility, and quality emphasizing a can do attitude and innovative approaches. Contribute to the overall management and oversight of the Pharmacovigilance Quality System. Develop and maintain a vision and strategy for nominated pharmacovigilance or regulatory processes. Coordinate and own the lifecycle management of nominated processes, enabling business continuity and compliance. Find opportunities to improve and simplify methodologies in processes and guidance, provide practical solutions, and drive implementation. Promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships. Lead the development or enhancement of standards or techniques to improve the quality, compliance, and efficiency of deliverables for the overall group. Develop and improve reporting tools and analysis processes and technology. Perform monitoring, analysis, and trending of data. Identify issues and risks and propose options to mitigate them. Monitor, interpret, and validate current, new, and changing legislation, handling the impact of changes. Ensure appropriate, up-to-date records are maintained for compliance. Participate in or support activities for GVP, GCP, GRP, and GMP audits/inspections. Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces. Provide process training to relevant functional groups. Seek personal and professional development opportunities and share knowledge gained in open forums. Represent AstraZeneca on industry bodies when appropriate. Serve as the delegate for Process Directors where appropriate. Contribute to communication and change management activities associated with process initiatives. Build relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships. Work collaboratively to provide expertise and share best practices across all regions and partnerships. Essential Skills/Experience A science/pharmacy/nursing degree with at least 5 years relevant experience (pharmaceutical, regulatory, safety, and partnership) Experience in working cross-functionally Leadership skills, including proven leadership of project teams experience Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues Thorough knowledge of the drug development process Good attention to detail Excellent written and verbal communication skills Proven track record to work across cultures Knowledge of AZ Business and processes Able to influence whilst maintaining an independent and objective view Strong collaboration skills Strong negotiation, conflict management, and interpersonal skills Relationship builder Able to work effectively as a member of a cross-functional or global team Understanding of change management process Desirable Skills/Experience MSC/PhD in scientific field Knowledge of new and developing regulatory and pharmacovigilance expectations Knowledge of existing AstraZeneca external alliances and collaborative projects Knowledge of CoE and CMO operating model Experience working with third-party suppliers Experience working in a global organization, preferably within the pharmaceuticals industry, with knowledge of the drug development life cycle and commercial aspects of the industry