Responsibilities:
• Support to set up the related system and safety database such as Oracle Argus Safety, ArisGlobal ARISg, Veeva VaultSafety, CRScube cubeSAFETY.
• Support to set up and update the related SOPs and ensure the regulatory compliance. 
• Support the PV related work in the clinical projects including but not limited to case processing, review of annual safety report, expedite/periodic reporting of safety information to regulatory authorities/investigators/IRBs/sponsors, and the preparation of safety management plan. 
• Support to perform post-marketing PV service tasks including but not limited to case handling, literature searching and reviewing, expedited / periodic reporting of safety information to regulatory authorities/sponsors in compliance with regulatory timelines. 
• Support to prepare periodic aggregate reports (PSUR/PBRER/DSUR) and Risk Management Plan.

Minimum Qualifications & Experience: 
• Bachelor of pharmacy/nursing/medicine/biology or a related major. A master/PhD degree is preferred. 
• 3+ years of PV relevant experience is preferred 
• Proficient knowledge of safety data base (such as Oracle Argus Safety, ArisGlobal ARISg, Veeva VaultSafety, CRScube cubeSAFETY) are preferred.

<기타사항>
- 급여: 회사 내규에 따름
- 근무지:  서울 강남구 테헤란로 124 삼원타워 20층 (2호선 강남역, 역삼역 사이 국기원 사거리 위치)