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 for leading and managing Lisbon GBS Patient Safety functions, ensuring timely and accurate processing 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 Expert collaborating with cross-functional teams and stakeholders to develop and deliver process excellence in line with agreed SLAs and performance KPIs.
Accountabilities & Responsibilities :
Regulatory Compliance
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Ensure compliance with global regulatory requirements, including timely submission of appropriate Regulatory Reports
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Serve as a subject matter expert during audits and inspections related to case intake processes within the hub
Leadership & Team Management
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Lead and manage the Case Intake Team Managers and teams, ensuring appropriate guidance, training, and performance management to maintain high-quality standards
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Maintain appropriate staffing levels in the hub, overseeing recruitment of new staff where required.
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Ensure that training and development of GBS PS staff results in consistent and compliant knowledge and skills within the hub
Service Delivery & Process Improvement
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Oversee the daily operations of the hub, ensuring efficient processing and reporting of adverse event cases within regulatory timelines
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Monitor and analyse case intake metrics for the hub, preparing reports on key performance indicators (KPIs) and identifying areas for improvement
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Annual update and testing of local Business Continuity Process (BCP)
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Implement and maintain standardised operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices
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Contribute to the development and optimisation of global patient safety processes, systems and tools, including automation solutions
Relationship Management
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Collaborate with GBS Patient Safety Hub Directors and the Global Patient Safety (GPS) team to improve processes and share best practices
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Work closely with internal stakeholders to grow and develop the function to support and enhance the wider GBS Business goals
General
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Dedicate time to self-development to ensure industry knowledge is kept up to date and personal objectives are achieved
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Work closely with GBS R&D Teams in the successful design and delivery of Business projects
Education, Qualifications, Skills, and Experience :
Essential
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Education: Degree in relevant field or equivalent experience
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Minimum of 5-7 years of experience in pharmacovigilance, with at least 3 years in a leadership role
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In-depth knowledge of global and regional pharmacovigilance regulations
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Knowledge of key industry standards and regulations that influence Global Patient Safety
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Exceptional attention to detail and commitment to maintaining high-quality standards in case processing and reporting
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Strong analytical and problem-solving skills, with the ability to interpret data and drive process improvements
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Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines
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Excellent leadership and team management skills, with the ability to motivate and develop staff in a multicultural environment
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Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders across different regions
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Excellent written and verbal communication skills in English
Desirable
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Education: Higher Degree (MBA, PHD) preferred in relevant field
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Proficiency in safety databases, ideally Argus, and case management systems
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Experience in delivering wide-scale transformation change programmes and projects
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