Senior Director Patient Safety Risk Management

At AstraZeneca we are dedicated to pushing the boundaries of science to deliver lifechanging 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 broadbased 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:

Lead the development of global risk management planrelated regulatory strategies in collaboration with Patient Safety Therapy Areas (PSTAs) clinical medical affairs and regulatory affairs.

Develop and maintain a framework for training and oversight in Risk Management Plan (RMP) strategy content standardization quality and implementation across TAs and MCs.

Lead the development of additional PV risk minimization strategies and assessment of effectiveness in collaboration with key partners and external vendors.

Oversee the design implementation and maintenance of additional risk minimization measures and materials.

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.

Perform quality reviews of Core & EU RMPs to ensure consistency across AZ and adherence to regulatory requirements.

Provide input into RMPrelated Health Authority negotiations.

Lead the development of methods and tools to maintain oversight of global legislative changes and inform RM strategy and objectives.

Provide input into draft regulatory guidance to prepare the organization for new RMrelated legislation.

Lead strategy in collaboration with key collaborators to coordinate capability building related to Risk Management planning within AZ.

Provide strategic leadership for the design and implementation of RM tools technology and methodology globally and locally.

Own the development of pioneering risk management/risk communication methods tools and technology.

Oversee the development and implementation of methods to facilitate shared learning across PSTAs and MCs for right first time filing strategies for RMPs.

Deliver significant contributions to scientific and technological innovation in risk minimization through external publications presentations and consortia.

Actively contribute to risk management plan audit plans and participate in related audits and inspections as required.

Contribute to the continuous improvement of risk management processes and procedures in collaboration with process owners.

Develop measurable objectives and delivery targets for the Risk Management group.

Lead the development of the longterm vision and mission of the Risk Management group.

Use expertise and knowledge of global issues to develop strategic Patient Safety/CoE objectives for inclusion in AstraZenecas annual business objectives.

Maintain a high degree of understanding and awareness of new Patient Safety trends and developments.

Essential Skills/Experience:

Health professional degree (MD PharmD RPh RN or related degree) or masters 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 maneuvering 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 stateoftheart risk management/risk communication methods tools and technology

RMPrelated 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 lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Date Posted