Introduction to role

Are you ready to turn vigilance into real-world impact by ensuring every safety report is handled accurately and on time? In this role, you will safeguard patients by transforming safety data into compliant action, supporting local Marketing Companies and collaborating closely with our international patient safety network.

You will act as a key liaison between local teams and Global Business Services Patient Safety (GBS-PS). You will manage the intake, processing, and communication of Individual Case Safety Reports (ICSRs). Trusted to take ownership of routine activities and resolve problems of moderate scope and complexity, you will help strengthen compliance, improve processes, and enable timely, well-informed decisions. Can you see yourself guiding colleagues through complex safety questions and making the right call when it matters?

Accountabilities

• ICSR Intake and Processing: Support the end-to-end intake, review, assessment, processing, tracking, and reporting of ICSRs from clinical, post-marketing, literature, and systematically gathered data sources, ensuring accurate data capture and compliant handling.
• Regulatory Liaison: Support timely responses to Health Authority queries relating to ICSRs and patient safety, with clear documentation and traceability.
• Quality Management and Compliance: Contribute to procedural document management, AE/PV training for internal teams and third-party suppliers, quality incident reporting, corrective and preventive actions, late-log processing, and continuous preparation for evaluations and examinations.
• Data Reconciliation and Screening: Perform reconciliations with internal and external partners to ensure the accuracy of pharmacovigilance data; conduct periodic screening of regulatory authority databases for adverse events and, where required, literature searches for the local product portfolio.
• Identify and route Product Quality Complaints and product security complaints. Ensure the information needed for adverse event reporting is collected and addressed accurately.
• Collaborator Mentorship: Provide patient safety expertise and mentorship to local functions, including Marketing, Sales, Regulatory Affairs, Medical Affairs, Clinical Operations, and other collaborators, on issue management, risk management, action plans, data gathering, and monitoring outcomes.
• External Partner Oversight: Support external service providers and collaboration partners in meeting AstraZeneca and local regulatory pharmacovigilance requirements, with clear expectations and effective working relationships.
• Follow-up and Documentation: Undertake manual follow-up using approved call scripts and resources; maintain effective filing, archiving, and retrieval practices for patient safety documentation.
• Training and Systems Enablement: Complete all required patient safety training and maintain access to relevant safety, regulatory, quality, HR, and commercial systems, as appropriate.
• Knowledge Stewardship: Maintain current knowledge of Taiwan regulatory requirements, global and local procedures and guidance, marketed product status, reference documents, and conditions, obligations, or commitments relating to product safety and the safe use of AstraZeneca products.
• Continuous Improvement and Projects: Contribute to pharmacovigilance activities for organised data collection programmes, digital and social media activities, licence partners, externally sponsored research, and other external collaborations; participate in ad-hoc local Marketing Company projects that enhance operational excellence.
• Values and Standards: Conduct all activities in line with AstraZeneca values, the Code of Conduct, established pharmacovigilance guidelines, and the policies and standards relevant to the role.

Essential Skills/Experience

• Degree or equivalent experience in Pharmacy, Medicine, Science, or a related field
• Strong pharmacovigilance and Good Pharmacovigilance Practice knowledge
• Knowledge of relevant Health Authority regulations, including Taiwan requirements
• Cross-functional and collaborative approach
• Effective and lateral thinking with strong problem-solving capability
• Vendor and external service provider management experience
• Excellent attention to detail
• Fluency in Chinese and English
• Excellent written and verbal communication skills

Why AstraZeneca

Join a distributed team committed to vigilance and precision in achieving meaningful outcomes for patients. You will work with colleagues across functions and borders, combining scientific rigour with digital tools to support smarter, faster decisions. Here, you are entrusted with responsibility, encouraged to challenge how things are done, and improve them, often alongside colleagues and partners who bring fresh perspectives. We value kindness alongside ambition and support your growth with opportunities to learn, contribute, and shape changes that matter.

If you are ready to protect patients while shaping how we deliver perfection in safety, step into this role and make your impact felt from day one.

Equal Opportunity

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.