Local Case Intake Service Manager

The Local Case Intake Service Manager - China is responsible for overseeing the local case intake service in China, ensuring efficient and compliant handling of adverse event reports. This role requires strong leadership skills, in-depth knowledge of pharmacovigilance regulations, and the ability to manage a team of service providers in a fast-paced environment.

Key responsibilities include:

• Leading and managing a local case intake team, providing guidance, training, and performance management to ensure high-quality standards in case processing
• Overseeing the intake, processing, and reporting of Individual Case Safety Reports (ICSRs) in compliance with the appropriate pharmacovigilance regulations and AZ standards

• Ensuring timely and accurate processing of information for all patient safety cases.

• Monitoring and analysing local case intake metrics for the local case intake team, preparing reports on key performance indicators (KPIs) and identifying areas for improvement

• Staying updated on changes to local and global pharmacovigilance regulations, ensuring consistency between global and local processes

• Participate in audits and inspections, ensuring the local case intake process is audit-ready

• Conducting quality checks on completed cases to verify accuracy, consistency, and compliance with all requirements

• Serving as a liaison between local and global levels, communicating changes related to the local pharmacovigilance organisation

• Managing service vendors and outsourced service providers (OSPs), including performance oversight, issue escalation and delivery against agreed service levels

• Participating in ad-hoc Global, Regional, or local MC case handling projects

Accountabilities & Responsibilities

• Maintain in-depth knowledge of the local health authority regulations and update regional lead & local teams with any new changes in legislation/guidance for discussion and escalation to relevant stakeholders in global Patient Safety as required.

• Ensure that local procedural documents/ standard operating procedures are followed for reporting/processing/ translation of AEs and are up to date & available for any patient safety audit and inspection.

• Support local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)

• Support the maintenance of local case intake and associated operational PV services processes

• Maintain current knowledge of the marketed status of products in the local country and reference documents (such as Product Information/Datasheet)

• Support full and prompt response to any patient safety query from the local regulatory authority related to patient safety function as determined by GBS and AstraZeneca agreed KPIs and SLAs.

• Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority.

• Support implementation and operational execution of local safety management agreements and clinical study protocols to fulfil AstraZeneca and local regulatory safety reporting requirements.

• Ensure timely submission of ICSR, follow-up cases, and other safety documents to local health authorities.

• Support Health Authority interactions and queries for ICSR handling related queries

• Ensure corrective and preventative actions are taken in the event of local non-compliance or breach of agreed SLAs.

• Support assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the AstraZeneca Always Serious List.

• Support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements.

• Establish strong relationships and effective cross-function collaboration with regulatory, marketing, medical, and other internal and external stakeholders’ functions to deliver patient safety requirements for business and regulatory needs.

• Ensure that the local case intake team completes all required patient safety training, global PS systems (e.g. Argus) and adheres to internal processes and external regulations. Act as a mentor to support newly appointed Case Intake Advisors

• Ensure an after-hours process is in place and maintained, to ensure a customer can report an AE and respond to regulatory authority questions.

• Oversee filing and archiving practices of patient safety documents.

• Ensure patient safety compliance data for the case intake team is up-to-date (e.g. monthly)

• Manage day-to-day relationships with service vendors and OSPs, monitor performance against contractual obligations, KPIs and SLAs, and coordinate timely resolution of service issues.

• Support the lifecycle management of vendor and OSP contracts, including requirements definition, renewals, amendments, governance, compliance and maintenance of appropriate records in collaboration with Procurement, Legal and Finance.

• Coordinate purchase orders and invoice processing for OSPs and vendors, validate charges against agreed services and budgets, resolve discrepancies, and support accurate forecasting and financial tracking.
• Ensure appropriate Local Case Intake Advisor cover is in place so that all activities continue to be performed within the required timeframes when out of the office, on holiday, unexpected leave etc.
• Support patient safety projects at local & global levels.

Education, Qualifications, Skills, and Experience

Essential

• Degree Qualified - Pharmacy/ Medical/ Science
• Thorough knowledge and experience of pharmacovigilance / Patient Safety within the pharmaceutical industry
• Thorough knowledge of the current pharmacovigilance and regulatory developments
• Experience in working cross-functionally
• Experience managing teams and vendors
• Ability to set and manage priorities, resource goals and project initiatives
• Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable

• Degree Qualified - Pharmacy/ Medical/ Science
• Ability to set and manage priorities, resource goals and project initiatives
• Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships

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.