서울특별시, 대한민국
Onsite
Introduction to role:
Are you ready to lead a high-performing group responsible for intake that ensures every adverse event report is captured, assessed, and reported with precision speed? Do you see yourself turning regulatory complexity into confident, timely decisions that safeguard patients and strengthen trust in Healthcare Authorities?
In this role, you will oversee local case intake across designated Marketing Companies in Korea, ensuring Individual Case Safety Reports are processed accurately and on time. Your leadership will translate data into action, driving consistent compliance, audit-readiness, and operational rigor that directly protects patients and supports the success of our medicines.
You will join an enterprise evolving through innovation, where digital tools and smart automation are harnessed to improve quality and efficiency. As a visible leader, you will connect local insight with worldwide safety frameworks. You will partner across functions and develop a culture of accountability and continuous improvement that delivers measurable impact.
Accountabilities:
Team Leadership and Development: Lead and coach a local case intake team, providing clear goals, ongoing training, and performance feedback to maintain high standards and build future capability.
Case Intake Excellence: Oversee end-to-end intake, processing, and reporting of ICSRs from clinical and post-marketing sources, ensuring accuracy, completeness, and timeliness.
Regulatory Compliance and SOP Governance: Maintain up-to-date local procedures aligned with global standards; ensure consistent adherence to SOPs and readiness for assessments and reviews.
You will guide Local Case Intake Advisors during interactions with public health agencies. Serve as the senior point of contact for complex customer concerns and ensure commitments are fulfilled.
Performance Metrics and Ongoing Improvement: Monitor benchmarks and SLAs, analyze trends, and drive targeted improvements to elevate quality, speed, and reliability.
Quality Oversight and Audit Readiness: Conduct quality checks, address deviations, and implement corrective and preventive actions to uphold compliance and inspection readiness.
Cross-Functional Partnership: Serve as a trusted liaison to Medical, Regulatory, Clinical, and Commercial teams, providing patient safety expertise that informs decisions and risk management.
Global-Local Alignment: Communicate local changes and insights to global collaborators; ensure local information is accurately reflected in the Pharmacovigilance System Master File.
Risk Management and Educational Materials: Support delivery of Risk Management Plan commitments, including oversight of related safety communications and materials.
Business Continuity and Coverage: Ensure robust after-hours processes and team coverage so that AE reporting and regulatory responses continue uninterrupted.
Systems and Data Stewardship: Oversee use of global patient safety systems (such as Argus), ensuring data integrity, proper documentation, and compliant archiving.
Project and Innovation Contribution: Contribute to local, regional, and global projects that enhance case handling, leverage digital channels, and strengthen the overall safety framework.
Essential Skills/Experience:
Korean citizen, fluent in both Korean and English
Degree in Pharmacy, Medical, or Science, or equivalent experience
Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry
Thorough knowledge of current pharmacovigilance and regulatory developments
Experience working cross-functionally
Ability to set and manage priorities, resource goals, and project initiatives
Ability to influence strategically while maintaining effective, positive organizational relationships
Excellent attention to detail
Excellent written and verbal communication skills
Desirable Skills/Experience:
Experience leading or managing case intake or patient safety teams
Hands-on experience with global safety databases and tools (for example, Argus)
Proven engagement with Health Authorities on ICSR-related queries and timelines
Participation in audits and inspections, with a strong track record of audit readiness
Familiarity with Quality Management Systems in pharmacovigilance and SOP lifecycle management
Knowledge of PSMF maintenance and local product information management
Exposure to Organised Data Collection Programmes and digital or social media AE intake
Experience mentoring advisors and establishing robust after-hours and coverage processes
Why AstraZeneca:
Here you will channel your expertise into work that matters, partnering across unexpected teams in the same room to unleash bold thinking and practical solutions that protect patients. You will operate within a collaborative, learning-focused community that values kindness alongside ambition, where digital innovation and rigorous compliance go hand-in-hand. With investment in technology and talent and a global network to learn from, you will have autonomy. You can run fast, make experienced decisions, and see your impact on patients and regulators.
Call to Action:
Make your next move count—lead this critical safety function in Korea and build the future of patient safety with purpose and precision.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, 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
17-Sept-2026Closing Date
29-Sept-2026AstraZeneca 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.
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