Associate Director, Pharmacovigilance Processes

Job Title: Associate Director, Pharmacovigilance Processes

Global Career Level: E

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are dedicated to following the science and pioneering new frontiers. Our team is committed to Oncology with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward by fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, collaboration, empowerment at every level, free inquiry, smart risk-taking based on scientific evidence. We have built an unrivaled scientific community both internally and externally by uniting some of the world's foremost medical centers. Working seamlessly together expedites research in some of the hardest-to-treat cancers. Join us to build a rewarding career as part of a team committed to improving millions' lives with cancer.

Ready to make a difference? Apply now!

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 authorisation and employment eligibility verification requirements.