Senior Director Patient Safety Risk Management

AstraZeneca; Luton; On-site; GBP 80,000 - 120,000

Job description

At AstraZeneca, we are dedicated to pushing the boundaries of science to deliver life-changing medicines. Our inclusive culture fosters collaboration across diverse teams, encouraging new ideas and innovation. With a dedication to lifelong learning and development, you will have all the tools you need to succeed. Join us on our mission to make a difference in medicine, patients' lives, and society.

Introduction to role:
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. You will develop innovative risk management methods, tools, and technology, ensuring quality and implementation across Therapeutic Areas (TAs) and Marketing Companies (MCs). 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.

Accountabilities, what you will do:

1. Lead the development of global risk management plan-related regulatory strategies in collaboration with Patient Safety Therapy Areas (PSTAs), clinical, medical affairs, and regulatory affairs.
2. Develop and maintain a framework for training and oversight in Risk Management Plan (RMP) strategy, content standardization, quality, and implementation across TAs and MCs.
3. Lead the development of additional PV, risk minimization strategies, and assessment of effectiveness in collaboration with key partners and external vendors.
4. Oversee the design, implementation, and maintenance of additional risk minimization measures and materials.
5. Lead all aspects of the review and endorsement of all Local Risk Management Plans (LRMPs) to ensure a consistent approach to LRMP content and compliance with Health authority requirements.
6. Perform quality reviews of Core & EU RMPs to ensure consistency across AZ and adherence to regulatory requirements.
7. Provide input into RMP-related Health Authority negotiations.
8. Lead the development of methods and tools to maintain oversight of global legislative changes and inform RM strategy and objectives.
9. Provide input into draft regulatory guidance to prepare the organization for new RM-related legislation.
10. Lead strategy in collaboration with key collaborators to coordinate capability building related to Risk Management planning within AZ.
11. Provide strategic leadership for the design and implementation of RM tools, technology, and methodology globally and locally.
12. Own the development of pioneering risk management/risk communication methods, tools, and technology.
13. Oversee the development and implementation of methods to facilitate shared learning across PSTAs and MCs for 'right first time' filing strategies for RMPs.
14. Deliver significant contributions to scientific and technological innovation in risk minimization through external publications, presentations, and consortia.
15. Actively contribute to risk management plan audit plans and participate in related audits and inspections as required.
16. Contribute to the continuous improvement of risk management processes and procedures in collaboration with process owners.
17. Develop measurable objectives and delivery targets for the Risk Management group.
18. Lead the development of the long-term vision and mission of the Risk Management group.
19. Use expertise and knowledge of global issues to develop strategic Patient Safety/CoE objectives for inclusion in AstraZeneca's annual business objectives.
20. Maintain a high degree of understanding and awareness of new Patient Safety trends and developments.

Essential Skills/Experience:

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

Desirable Skills/Experience:

1. Regulatory strategy knowledge and experience.
2. Strategic knowledge of global healthcare systems.
3. Proven ability to lead teams and projects across a wide variety of stakeholders.
4. Proven ability to develop state-of-the-art risk management/risk communication methods, tools, and technology.
5. 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!

Date Posted: 10-Mar-2025

Closing Date: 31-Mar-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.