Contribute to Safety Management in Global Clinical Trials
Opportunity to Contribute to Clinical and Post-Marketing Studies
- Industry-leading global pharmaceutical company with rich development pipeline in oncology, immunology and CNS
- Take full responsibility to create, implement and verify J-RMP including all risk minimization activities for EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices of responsible products/compounds.
- Take full responsibility to prepare and assess a summary of aggregate reports, revision of package inserts, Reexamination dossier, GPSP compliance inspection, Early Post-marketing Phase Vigilance, responses to regulatory inquiries, and others.
- Collaborate with members of JRML and PMSO for above mentioned activities in responsibl products/compounds.
- Take a role as a core J-SMT member in collaboration with JPKK's key stakeholders including JCoT members in responsible products/compounds.
- In a way that supports JRML, liaise with all other internal and external key stakeholders of responsible products/compounds.
- Join related committee including partner companies as a representative of J-SMT of responsible products/compounds.
- Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with JRML and Strategic Risk Communication Group.
Experience in PV operations
Deep understanding of a series of PV operations, such as monitoring, triage, inputting, QC, and adverse event reports to local regulatory authorities
Able to perform PV operations independently without supervision
English ability to able to communicate effectively with global counterparts and sponsors
Experience in using safety databases such as Argus and Aris
Experience in PV input, evaluation and / or QC functions.
Basic skills in Word, Excel and Outlook
- Pharmacist, nurse, or other scientific experience is preferred
- Opportunity to work on global studies
- Contribute to PMS and clinical studies