Local Case Intake Advisor, GBS Patient Safety (Secondment - 12 months)

The Case Intake Advisor is responsible for managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level.  This role will support specific local Marketing Companies to ensure compliance with Astra Zeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison point between those Marketing Companies and GBS-PS. 

The role will support activities of the GBS-PS function and work under the guidance of Case Intake Team Managers with the expectation to deliver routine activities independently including resolving problems of moderate scope and complexity, conducting activities and interactions consistent with company values and in compliance with the Code of Conduct, supporting policies and standards relevant to the role. 

Core responsibilities may include: 

• Supporting Individual Case Safety Reports (ICSRs) processing and handling, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products. 

• Supporting Health Authority interactions, such as for ICSR related queries. 

• Contribution to effective operational implementation of the Quality Management System appropriate to the GvP discipline, including procedural document management, implementation of AE/PV training requirements across internal personnel and third-party suppliers, managing quality incident reporting, and audit & inspection readiness. 

• Contributing to the PV aspects relating to Organised Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Licence Partners (LP), Externally Sponsored Research (ESR), ODCP providers, partnerships or other collaborations etc). 

• Provide Local Case Intake expertise and guidance and collaborate with the local Patient Safety Team to manage and resolve related issue. 

• Participating in ad-hoc local Marketing Company projects 

Additionally, the Case Intake Advisor should: 

• Ensure conduct of PV and submission of all PV-related documents is in accordance with MC requirements, internal procedures and Good Pharmacovigilance Practice (GVP) 

• Establish strong relationships and effective collaboration with Local Patient Safety Team and other internal and external stakeholders' functions to deliver patient safety requirements for business and regulatory needs  

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role.  

The Local Case Intake Advisor will be fluent in English.