[Novotech] Sr. Pharmacovigilance Associate 정규직 채용

[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.

• 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.

• Fluent in both written and oral English