Senior Director Patient Safety Risk Management

At AstraZeneca, **Global Patient Safety (GPS)** is at the forefront of defining and optimising 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 critical 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 report to the Executive Director, Safety Epidemiology and Risk Management and will focus primarily on the **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 collaborate with key partners to develop global risk management strategies and guiding the authoring of Core and EU Risk Management Plans. You will contribute to regulatory strategies, and novel methodologies that advance the field of risk management and risk minimisation. Your contributions will be recognized both internally and externally as you work on complex strategic problems and provide innovative solutions. You will develop innovative risk minimisation methods, tools, and technology, ensuring quality and implementation across the markets..

**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, crafting 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 feedback to improve risk management processes and set measurable targets for the Risk Management team.
- Inspire 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 state-of-the-art risk management/risk communication methods, tools, and technology
- RMP-related publications, presentations, and representation/leadership in relevant external professional bodies/consortium

**Location**: Luton UK, Barcelona Spain, Gaithersburg or Wilmington US

**Salary**: Competitive + Excellent Flexible Benefits

**Where can I find out more?**

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