GBS Patient Safety Hub Associate Director
AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients delivering 20 new medicines to patients 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 whole 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.
This role is responsible forleading and managing Lisbon GBS Patient Safety functions,ensuringtimely and accurateprocessing and reporting of local adverse event cases. Leading a team of c.20, this role requires a combination of leadership skills, a deep understanding of global pharmacovigilance regulations, and experience in the delivery of services that meet and exceed client expectations.
The successful candidate will act as a PV Subject Matter Expertcollaborating with cross-functional teams and stakeholdersto develop and deliver process excellence in line with agreed SLAs and performance KPIs.
Accountabilities & Responsibilities :
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
Lead and manage the Case Intake Team Managers and teams, ensuring appropriate guidance, training, and performance management to maintain high-quality standards
Maintain appropriate staffing levels in the hub, overseeing 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
Service Delivery & Process Improvement
Oversee the daily operations of the hub, ensuring efficient processing and reporting of adverse event cases within regulatory timelines
Monitor and analyse case intake metrics for the hub, preparing reports on key performance indicators (KPIs) and identifying areas for improvement
Annual update and testing of local Business Continuity Process (BCP)
Implement and maintainstandardised operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices
Contribute to the development and optimisation of 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 share best practices
Work closely with internal stakeholders to grow and develop the function to support and enhance the wider GBS Business goals
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
Education, Qualifications, Skills, and Experience :
Essential
Education: Degree in relevant field or equivalent experience
Minimum of 5-7 years of experience inpharmacovigilance, with at least 3 years in aleadership role
In-depth knowledge of global and regional pharmacovigilance regulations
Knowledge of key industry standards andregulations that influence Global Patient Safety
Exceptional attention to detail and commitmentto maintaining high-quality standards in caseprocessing and reporting
Strong analytical and problem-solving skills,with the ability to interpret data and driveprocess improvements
Ability to work in a fast-paced environment,manage multiple priorities, and meet tightdeadlines
Excellent leadership and team managementskills, with the ability to motivate and developstaff in a multicultural environment
Excellent communication skills, both writtenand verbal, with the ability to interact effectivelywith internal and external stakeholders across different regions
Excellent written and verbal communication skills in English
Desirable
Education: Higher Degree (MBA, PHD) preferred in relevant field
Proficiency in safety databases, ideally Argus, and case management systems
Experience in delivering wide-scale transformation change programmes and projects
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 authorisation and employment eligibility verification requirements.
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