Associate II PSS (1 year contract)
On-siteSeoul, Seoul, South Korea
Job Summary
Manage receipt and processing of all adverse event reports, including spontaneous and solicited data from clinical trials and post-marketing settings. Perform data entry onto adverse event databases, review reports for completeness and accuracy, and write patient narratives using MedDRA coding. Identify missing clinically significant information, ensure appropriate medical review, and expedite Serious Adverse Event (SAE) reporting to regulatory agencies and clients within specified timelines. Submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), maintain tracking systems, and support database reconciliation with Data Management teams. Conduct quality or peer reviews of processed reports, assist in root cause analysis and CAPA plan development, and prepare for audits and inspections. Maintain comprehensive understanding of Standard Operating Procedures and support safety committee activities.
Required Qualifications
- Non-degree + 2 yrs. safety experience
- Associate degree + 2 yrs. safety experience
- BS/BA + 1 year of Safety experience
- MS/MA + 1 year of Safety experience
- PharmD + 1 year of Safety experience
- Degree preferred to be in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area
- High degree of accuracy with attention to detail
- Functions as a team player
- Good written and verbal communication skills
- Ability to work independently with minimal supervision
- Good keyboard skills with knowledge of MS Office and Windows application
Desired Qualifications
- Good Presentation skills
- Training and mentoring skills
- Office Environment or remote
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