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PV Officer
Tokyo 23 Wards
Permanent
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Contribute to Safety Management in Global Clinical Trials
Join a Leading PV Specialized CRO - Expanding Operations in APAC
About Our Client
- Leading Pharmacovigilance and Medical Information specialised global CRO delivering across 100 countries worldwide
Job Description
- Proactively providing case processing activities as requested to ensure high-quality individual case safety reports of adverse events
- Provide accurate individual case reports for submission to regulatory authorities, sponsors and and participating clinical trial investigators in compliance with regulatory requirements and time frames for reporting
- Serve as a member of project teams. Communicate timelines, delivering quality and timely input to meet the needs of the project team and informs the project team on the status of activities and issues
- Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes
- Revises and maintains processes and procedures for drug safety in compliance with regulatory requirements and company standards
- Support Pharmacovigilance Audits and Inspections as needed concerning the Global Case Management function.
Any other activity that may reasonably be required
The Successful Applicant
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Experience in PV operations
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Deep understanding of a series of PV operations, such as monitoring, triage, inputting, QC, and adverse event reports to local regulatory authorities
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Able to perform PV operations independently without supervision
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English ability to able to communicate effectively with global counterparts and sponsors
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Experience in using safety databases such as Argus and Aris
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Experience in PV input, evaluation and / or QC functions
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Basic skills in Word, Excel and Outlook
- Pharmacist, nurse, or other scientific experience is preferred
What's on Offer
- Contribute to exciting start up of global CRO in Japan