Local Case Intake Advisor - Global Business Services

Job Description

Job Title: Local Case Intake Advisor (Chinese language)- Global Business Services

Career Level - C

Introduction to role

Are you passionate about patient safety and compliance? As a Local Case Intake Advisor, you will manage the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. You will support specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison between those Marketing Companies and GBS-PS. This role requires fluency in English and involves working under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and conduct activities consistent with things we value and compliance standards.

Accountabilities

• Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs).
• Review, assess, and process safety data from various sources, distributing reports to internal and external third parties.
• Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting.
• Provide prompt support for regulatory authority queries related to the Patient Safety function.
• Implement Corrective and Preventative Actions in the event of local non-compliance.
• Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received.
• Periodically screen regulatory authority databases for adverse events.
• Perform literature search and related activities for MC product portfolio if required.
• Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts.
• Maintain filing and archiving practices of patient safety documents.
• Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready.
• Support external service providers to meet company and local regulatory PV requirements.
• Assist the local PS team in audits or regulatory authority inspections.
• Complete all required patient safety trainings and obtain access to relevant systems.
• Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety.

Essential Skills/Experience

• Degree Qualified – Pharmacy/ Medical/ Science
• Language skill - Chinese
• Pharmacovigilance knowledge excellence
• Good Pharmacovigilance Practice
• Knowledge of health authority regulations
• Cross-functional collaborative approach
• Effective and lateral thinking
• Problem solving
• Vendor management
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable Skills/Experience

• Influencing and Conflict Resolution skills
• Medical knowledge in company Therapeutic Areas
• Project management
• Successful participation in above-market projects
• Audit & Inspection experience

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, our work has a direct impact on patients, transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions in a dynamic environment that encourages lifelong learning.

Ready to make a difference? Apply now to join our team!

Date Posted

Closing Date

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.