Sr. Pharmacovigilance Associate 채용

[노보텍아시아코리아] Sr. Pharmacovigilance Associate 채용

[모집기간]

07월 08일 ~ 08월 07일

[담당업무]

-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. 

-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.

-Good in both written and oral English

[우대사항]

-의/약학, 간호학, 생명/환경공학

-영어가능자, 해당직무 근무경험

[채용공고]