Pharmacovigilance Specialist

Description

• Korea Health Authority (HA) Case Download / Case Handling (Primary Responsibility)
• Perform daily monitoring and retrieval of adverse event (AE) from MFDS portals (e.g., KAERS).
• Upload HA downloaded cases into the global PV system using the Progressive Intake Tool in a timely and accurate manner.
• Verify data quality and completeness; resolve discrepancies or system-related issues.
• Coordinate with the Global PV (GPV) team for follow-up queries, clarifications, or data corrections.
• Global PV Regulatory Intelligence (PV RI) Support
• Monitor updates from global PV guidelines and regulatory sources.
• Summarize changes and confirm the potential impact with relevant stakeholders.
• Maintain and update the PV Regulatory Intelligence tracker.
• Distribute updated guidelines and regulatory requirements to global and local stakeholders in a timely and structured manner.
• Local Pharmacovigilance (PV) activities Support
• Support daily PV activities under the supervision of the Local Safety Responsible.
• Assist in preparing PV documentation and reports required by local regulations and global policies.
• Support local PV compliance activities including audit readiness, inspection preparation, and SOP updates.
• Assist with local literature monitoring activities, if applicable.
• Provide administrative and operational support as needed for local PV processes.
• Cross-functional Collaboration & Operational Support
• Work closely with internal teams to ensure regulatory and PV requirements are aligned across functions.
• Explain technical or regulatory information clearly to team members and cross-functional partners.
• Depending on business needs, responsibilities may expand to broader operational support

Qualifications

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related field preferred.
• Experience in pharmacovigilance but not mandatory (training provided).
• Effective communication skills in both Korean and English.
• Strong sense of responsibility, ability to prioritize, and a compliance-oriented mindset.