Job Description

At AstraZeneca,

Global Patient Safety (GPS)

is at the forefront of defining and optimizing the safety profile of our medicines across their lifecycle in all therapeutic areas. GPS leads the way in integrating science, data, and technology to shape clinical safety strategies. From monitoring and detection to characterization and reporting of adverse events, GPS plays a meaningful role in ensuring the safety of our medicines for patients worldwide.


Are you ready to lead and innovate in the field of patient safety and risk management? As a

Senior Director of Patient Safety Risk Management

, you will demonstrate your specialist knowledge in risk management and broad-based expertise in patient safety to provide strategic direction and leadership. The role will be aligned to AstraZeneca's diverse and expansive

Oncology

therapy area, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us.


You will develop innovative risk management methods, tools, and technology, ensuring quality and implementation across

Global Oncology Patient Safety

and

locally aligned countries

. Collaborate with key partners to develop global risk management plans, regulatory strategies, and novel methodologies that advance the field of risk management. Your contributions will be recognized both internally and externally as you work on complex strategic problems and provide innovative solutions.

Key Accountabilities:

Spearhead the development of global risk management strategies in partnership with Oncology Patient Safety, Clinical, Medical Affairs, and Regulatory Affairs teams. Build and sustain a comprehensive framework for training and oversight on Risk Management Plan (RMP) strategies, ensuring standardization, quality, and seamless implementation across global operations. Drive the creation and assessment of additional pharmacovigilance measures and risk minimization strategies, working alongside key partners and external vendors. Guide and endorse Local Risk Management Plans (LRMPs) to ensure uniform content and compliance with health authority regulations. Conduct detailed reviews of Core & EU RMPs to maintain consistency and regulatory adherence across AstraZeneca. Contribute strategic insights during Health Authority negotiations related to RMP. Develop innovative methods and tools to keep abreast of global legislative changes, shaping our risk management strategies and objectives. Champion capability building in Risk Management planning through cross-functional collaboration. Lead the strategic design and implementation of risk management tools, methodologies, and innovative technology both locally and globally. Promote shared learning for optimized RMP filings and contribute to leading scientific advances in risk minimization. Participate in audits, offering strategic input to improve risk management processes and set measurable targets for the Risk Management team. Encourage and drive the long-term vision and objectives for the Risk Management group, aligning with global patient safety trends and developments.

Essential Skills/Experience:

Health professional degree (MD, PharmD, RPh, RN, or related degree) or master's degree in life sciences or related field Extensive experience in patient safety/pharmacovigilance and risk management, including applicable industry experience Ability to rapidly comprehend the AZ organization and agility in manoeuvring across the organization Ability to lead, develop, and implement RM strategy regarding patient risk management across geographies and multiple functions including commercial, medical affairs, and patient safety Excellent strategic thinking capability

Desirable Skills/Experience:

Regulatory strategy knowledge and experience Strategic knowledge of global healthcare systems Proven ability to lead teams and projects across a wide variety of stakeholders Proven ability to develop pioneering risk management/risk communication methods, tools, and technology RMP-related publications, presentations, and representation/leadership in relevant external professional bodies/consortium

Location:

Luton UK

Salary:

Competitive + Excellent Flexible Benefits!


Ready to take on this exciting challenge? Apply now!

Where can I find out more?

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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.