he Specialist Local Medical Safety, Korea(PV Specialist) is responsible for ensuring that all pharmacovigilance (PV) activities at the Local Operating Company (LOC) are conducted in compliance with local regulatory requirements and company policies at local, regional, and global levels.

This role supports safety reporting, risk management activities, and regulatory compliance to ensure patient safety.

Key Responsibilities

• Ensure LOC safety activities comply with local regulations and internal PV procedures
• Support safety reporting activities in accordance with regulatory requirements and company standards

• Support activities related to safety reporting required by Marketing Authorization Holders (MAH) and/or study sponsors
• Assist in ensuring timely and accurate submission of safety reports

• Support the preparation of Local Risk Management Plans (RMP) and documentation required for license renewal
• Monitor and track implementation of additional risk minimization activities

• Ensure proper training documentation on safety reporting responsibilities for LOC personnel
• Maintain awareness and compliance culture around pharmacovigilance processes

• Collaborate with internal stakeholders across functions and regions
• Support cross-functional projects within International Pharmacovigilance (IPV)

• Support compliance-related PV activities in Korea and APAC region

Qualifications

• Bachelor’s degree or above in Health, Life Sciences, Pharmacy, or related field
• Pharmacist license preferred

• Minimum 2+ years of experience in pharmacovigilance or related areas(e.g., CRA, MIS, Hospital Pharmacist)
• Prior PV experience preferred