Job Title: GBS Patient Safety Senior Director

Introduction to role:

AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients by delivering 20 new medicines by 2030. This role is critical in contributing to AZ’s long-term ambition. Global Business Services (GBS) is growing to support critical functions across the entire enterprise. This role will be specifically focused on defining and delivering GBS opportunities within the R&D areas of the business. GBS is enhancing its customer focus by establishing Research & Development (R&D) Services to improve alignment and strengthen our relationships with SET areas. R&D Services is a key element of the GBS Bold Ambition, driving our vision to enable AstraZeneca to change and grow at speed. Between now and 2030, 10 new R&D capabilities are to be established, ensuring that GBS can offer the broad range of services required to support AZ ambitions.

The Patient Safety Senior Director is responsible for leading the teams that deliver Patient Safety-specific services to R&D Global Patient Safety Local Markets within the GBS organisation. This role entails aligning services with customer strategies, proactively identifying capability gaps or opportunities for improvement, and fostering collaboration between direct reports and partnering teams. This role is critical in ensuring the success of this important and strategic partnership. By having a deep knowledge and extensive experience in pharmacovigilance and a deep understanding of global regulatory requirements, the Director will ensure that the delivery of services is efficient, effective, and aligned with the strategic objectives and regulatory requirements. This role requires a strategic leader with strong organisational and communication skills, capable of driving improvements and fostering a collaborative work environment.

Accountabilities:

• With the Head of GBS R&D Services, manage the relationship with Global Patient Safety (GPS). This will include working with GPS to ensure oversight of Patient Safety strategic initiatives and continuous improvements, jointly resolving issues escalated from GBS Patient Safety operations and following up on KPI trends /SLAs/Satisfaction.
• Develop and implement global strategies to optimise Patient Safety processes, ensuring efficiency, quality, and compliance across all geographic hubs.
• Lead and manage a team of Patient Safety Hub Directors and teams, providing guidance, mentorship, and performance management.
• Establish and maintain standardised operating procedures (SOPs) for case intake and processing, ensuring consistency and regulatory compliance.
• Oversee the implementation and optimisation of global patient safety processes, systems, and tools, including automation solutions. GPS own and maintain the AZ Patient Safety database.
• Collaborate with cross-functional teams, including HR, Global R&D IT, and Audit, to ensure seamless integration of Patient Safety activities.
• Keep track of global Patient Safety metrics and essential performance indicators. Where required, initiate and oversee continuous improvement initiatives.
• Serve as the primary point of contact for regulatory authorities during inspections and audits related to global case intake processes.
• Manage relationships with external vendors and partners, ensuring compliance with contractual obligations and maintaining high-quality standards.
• Stay informed about evolving global pharmacovigilance regulations and standard methodologies, implementing necessary changes to ensure compliance across all hubs.
• Ensure that training and development of GBS Patient Safety staff results in consistent and compliant knowledge and skills across all hubs.

Essential Skills/Experience:

• Education: Degree in relevant field or equivalent experience
• Minimum of 10-15 years of experience in pharmacovigilance, with at least 5 years in a senior leadership role supervising global operations
• Knowledge of key industry standards and regulations that influence Global Patient Safety
• Extensive knowledge of global pharmacovigilance regulations, including ICH guidelines, FDA, EMA, and other regional requirements
• Proven track record in managing and optimising global pharmacovigilance processes and systems
• Demonstrated ability to manage complex projects and drive organizational change
• Proven track record of delivery of global projects and the development of pragmatic solutions
• Excellent analytical and problem-solving abilities, with a focus on process improvement and innovation
• Strong leadership skills with experience managing multi-functional, diverse, multi-cultural teams across different geographic locations
• Strong interpersonal and leadership skills to build relationships with key partners across cultures
• Outstanding communication and interpersonal skills, with the ability to interact effectively with senior management, regulatory authorities, and external partners
• Excellent written and verbal communication skills in English
• Proven experience in building and managing high-performing teams, adhering to critical metrics/SLAs and high-level account management/Business Partnering
• Ability to work in a team environment / works collaboratively across multi-functional teams at a high level
• Flexibility to travel internationally as required (up to 25%)

Desirable Skills/Experience:

• Education: Higher Degree (MBA, PhD) preferred in relevant field
• In-depth understanding of pharmacovigilance databases and automation tools
• Extensive Programme & Project management experience
• Understanding of GBS models and capabilities

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, you'll be valued for your niche knowledge. We are trusted with personal accountability to live up to our full potential and make a contribution. We get to challenge the way we work to find better ways to make a bigger impact on the business and patients' lives. From embracing innovative technology to reimagining technical practices.

Ready to make an impact? 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 authorization and employment eligibility verification requirements.