Key Responsibilities:

1. Adverse Event (AE) and Safety Data Management:
   • Collect, process, and submit AEs in compliance with local regulations.
   • Manage safety databases and perform literature screening for safety content.
2. Compliance and Reporting:
   • Ensure timely reporting, PSUR submissions, and PV training compliance.
   • Conduct case reconciliation and maintain local regulatory intelligence.
   • Participate in local/global PV audits.
3. Risk Management and SOPs:
   • Develop and implement Risk Management Plans (RMPs).
   • Create and maintain SOPs to meet regulatory requirements.
4. Training and Communication:
   • Provide PV training for staff and partners.
   • Manage health authority communications.

Qualifications:

• Bachelor’s degree in pharmacy or related field; Licensed Pharmacist (Mandatory).
• 2+ years of PV experience in pharmaceuticals or medical devices.
• Strong knowledge of local/global PV regulations (e.g., ICH, GVP).
• Proficient in safety data management systems and reporting tools.
• Fluent in English and Korean (written and spoken).
• Detail-oriented, with excellent communication, analytical, and problem-solving skills.