KEY RESPOSIBILITIES

1. Adverse Event (AE) and Safety Data Management

Collect, process, translate, and submit AEs from all sources (PMS, QA, and Medical Information) to CDS in compliance with local regulations.Manage the safety database, including data entry, consistency review, follow-up reporting, and document archiving.Perform local literature screening for safety-related content.

2. Compliance and Reporting

Monitor the timeliness of expedited reporting, PSUR submissions, and PV training completion.Conduct case reconciliation with relevant departments and business partners to ensure compliance.Maintain local regulatory intelligence, assess its impact on processes, and communicate changes to CDS.Perform local or global PV audit.

3. Risk Management and SOP Implementation

Establish and implement the Risk Management Plan (RMP).Generate and maintain SOPs to ensure adherence to local regulatory requirements.

4. Training and Communication

Provide PV training to internal staff, new hires, and external partners (including agencies and CROs).Receive and forward health authority communications to CDS.

JOB QUALIFICATION

Bachelor’s degree in pharmacy or a related field.Licensed Pharmacist (Mandatory).Minimum 2 years of experience in Pharmacovigilance (PV) in the pharmaceutical or medical device industry.Strong knowledge of local regulatory requirements and global PV guidelines (e.g., ICH, GVP, and local health authority regulations).Proficiency in safety data management systems and reporting tools.Excellent communication and collaboration skills with internal teams, health authorities, and external partners.Ability to conduct literature reviews and manage safety-related processes effectively.Detail-oriented with strong analytical and problem-solving skills.Proficiency in both English and Korean (written and spoken) for regulatory reporting and communication.