Job Title: Patient Safety Case Intake Advisor (Thai Speaker) - Global Business Services
Introduction to role
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 Global Business Services-Patient Safety (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 Patient Safety expertise and guidance within the local Marketing company (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs) related to issue management for key products, risk management, formulating action plan/implementation, information gathering/extracting data, monitoring results of actions plans, and provide safety data expertise
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 and Good Pharmacovigilance Practice (GVP)
Establish strong relationships and effective collaboration between regulatory, marketing, clinical 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.
Accountabilities
Support provision of the following activities:
Pharmacovigilance activities including local processes, procedures and systems in place for collection, reporting and tracking of Adverse Events (AEs), handling of Individual Case Safety Reports (ICSRs) for AEs from clinical and post-marketed sources (including literature) and Organised Data Collection Programs.
Review, assessment and processing of safety data and information received from various sources, distributing reports and/or metrics onwards to both internal and external third parties following applicable regulations and standard operating procedures (SOPs), under guidance and support of the appropriate Local Case Intake Team Managers and/or senior team members.
Identification of Product Quality Complaint (PQC) and Product Security complaints, including collection of information necessary for AE complaint reporting.
Prompt support for responses to any queries from regulatory authorities related to the Patient Safety function.
Implementation of Corrective and Preventative Actions in the event of local non-compliance and processing of completed late logs.
Reconciliations ensuring the accuracy of pharmacovigilance data that is transferred and received.
Periodic screening of regulatory authority database for adverse events.
If required, perform literature search and related activities for MC product portfolio.
Undertake manual follow-up where required disseminating clear and accurate information based on approved call scripts and/or other AZ approved resources.
Filing and archiving practices of patient safety documents.
Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety related processes and brand activities within countries of remit and being audit and inspection ready.
Support external service providers to meet the company and local regulatory PV requirements.
Support the local PS team in relation to audits or regulatory authority inspections.
Complete all required patient safety training in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate.
Maintain current and in-depth knowledge of:
Relevant country regulatory authority regulations
Global and local procedural and guidance documents
Marketed status of products in the local country and reference documents (i.e. Core Data Sheet)
Conditions, obligations and other commitments relating to product safety or the safe use of AZ products
Essential Skills/Experience
Degree Qualified – Science/Life Sciences
Life sciences knowledge excellence
Proficient in Thai language (both written and spoken) is required
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!