Clinical Safety Scientist
Contribute to Safety Management in Global Clinical Trials
Opportunity to Contribute to Clinical and Post-Marketing Studies
About Our Client
- Industry-leading global pharmaceutical company with rich development pipeline in oncology
- To develop and maintain the Risk Management Plan of the products in Japan based on the PV activities' results and other information.
- When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related internal parties including JPV team and Global patient safety with external parties (including co-proportioned company, PMDA and MHLW etc.).
- Managing quality Pharmacovigilance deliverables such as RMP(Revision), EPPV report, PMS report, J-PSUR and Re-examination package etc. of the assigned products/projects throughout the product's lifecycle.
- Work on management of PMS study, EPPV and communication of Safety Assurance Measure as PV associate member.
The Successful Applicant
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
What's on Offer
- Opportunity to work on global studies
- Contribute to PMS and clinical studies