注目の求人情報
PV Country Lead - Specialized Healthcare Company
東京23区
正社員
- 応募
- 求人を送信
- 求人を保存
Bullet points
Lead 立ち上げ Activities for Japan Business
Manage and Oversee all of Japan Pharmacovigilance Operations
企業情報
- Leading Pharmacovigilance and Medical Information global CRO delivering across 100 countries worldwide
職務内容
- Manage the overall business operations in Japan, including locating and establishing office location and facilites
- Responsible for performing critical safety oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner
- Accountable for coordination of day-to-day operational ICSR activities in collaboration with sponsor and global HQs
- Responsible for facilitation of training and development of PV and MI personnel (remotely and on-site)
- Lead Safety Operations in ensuring all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner
- Manage SAE/SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure clinical trials case reporting process is efficient and compliant with reporting requirements)
- Maintenance of electronic safety database for tracking, storing, and reporting of serious adverse events
- Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP)/ PV agreements and safety data exchange agreements
- Review incoming adverse events to determine action required
理想の人材
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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
条件・待遇
- Contribute to 立ち上げ for Japan Office
- Oversee execution of all PV related activities in Japan
- Lead account management of established clients in Japan
- Responsible for the management, on-boarding and training of PV staff