Job Title: GBS Patient Safety Hub 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. The Patient Safety Hub Director is responsible for leading and managing our GBS Patient Safety Hub in Bangalore, ensuring timely and accurate processing and reporting of Hub activities; including local adverse event cases, Literature Reviews, and Regulatory Reporting, supported by effective training and QC activities. Leading a team of over 80, this role requires a combination of leadership skills, a deep understanding of global pharmacovigilance regulations, and experience in the delivery of services in a large-scale operation that meets and exceeds client expectations.

Accountabilities:

Regulatory Compliance

• Ensure compliance with global regulatory requirements, including timely submission of appropriate Regulatory Reports
• Serve as a subject matter expert during audits and inspections related to case intake processes within the hub

Leadership & Team Management

• Maintain appropriate staffing levels in the hub, supervising recruitment of new staff where required
• Ensure that training and development of GBS PS staff results in consistent and compliant knowledge and skills within the hub
• Lead and manage the Team Managers and Case Intake, Training, Quality & Compliance, Regulatory Reporting and Literature Review teams, ensuring appropriate guidance, training, and performance management to maintain high-quality standards

Service Delivery & Process Improvement

• Oversee the daily operations of the hub, ensuring efficient processing and reporting of adverse event cases, Literature Reviews, and Regulatory Reporting activity within Health Authority timelines
• Monitor and analyse case intake metrics for the Bangalore Hub, preparing reports on key performance indicators (critical metrics) and identifying areas for improvement
• Annual update and testing of local Business Continuity Process (BCP)
• Implement and maintain standardised operating procedures (SOPs) for case intake processing, Literature Reviews, and Regulatory Reporting, ensuring consistency with global pharmacovigilance practices
• Contribute to the development and optimisation of all global patient safety processes, systems, and tools, including automation solutions

Relationship Management

• Collaborate with GBS Patient Safety Hub Directors and the Global Patient Safety (GPS) team to improve processes and exchange standard methodologies
• Collaborate closely with internal collaborators to improve the function and contribute to the overall GBS Business objectives

General

• Dedicate time to self-development to ensure industry knowledge is kept up to date and personal objectives are achieved
• Work closely with GBS R&D Teams in the successful design and delivery of Business projects
• Stay updated on regional and global pharmacovigilance regulations for those MCs supported by the Bangalore Hub, ensuring that necessary changes are implemented to maintain compliance

Essential Skills/Experience:

• Education: Degree in relevant field or equivalent experience  
• Demonstrated ability in pharmacovigilance, with at least 5-8 years in a leadership role
• In-depth knowledge of global and regional pharmacovigilance regulations
• Experience in delivering wide-scale transformation change programmes and projects
• Knowledge of key industry standards and regulations that influence Global Patient Safety
• Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines
• Excellent leadership and team management skills, with the ability to motivate and develop staff in a multicultural environment
• Strong analytical and problem-solving skills, with the ability to interpret data and drive process improvements
• Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders across different regions
• Ability to work within a complex matrix / works collaboratively
• Exceptional attention to detail and commitment to maintaining high-quality standards in case processing and reporting
• Excellent written and verbal communication skills in English
• Leader and self-starter
• Track record in managing and optimising Patient Safety processes

Desirable Skills/Experience:

• Education: Higher Degree (MBA, PhD) preferred in relevant field  
• Proficiency in safety databases, ideally Argus, and case management systems
• Track record in managing and optimising Patient Safety processes 

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 will be part of a team of specialists that is valued and essential to our growth. We are empowered to challenge the status quo, apply innovative thinking, and make things happen in a creative yet rigorous environment. Our strength lies in our global network where we collaborate seamlessly across diverse teams. The business invests in our growth and development, keeping us ahead of our peers. Here you can make an impact on patients' lives while growing your career.

Ready to make a difference? 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.