[근무부서 및 직급/직책]

• 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.

[자격요건]

•  Bachelor of pharmacy/nursing/medicine/biology or a related major. A master/PhD degree is preferred. 

•  1 year or above Clinical /PV relevant experience is preferred for PV Associate/Specialist; and 2.5 years or above PV relevant experience is preferred for senior PV Associate/Specialist. 

•  Proficient knowledge of safety data base (such as Oracle Argus Safety, ArisGlobal ARISg, Veeva VaultSafety, CRScube cubeSAFETY) are preferred.

• Fluent in both written and oral English