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| 部署・役職名 | 【柔軟的な勤務形態・幅広いPV業務担当】PV Sr. Associate, Japan Safety |
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| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
こんな方なら向いている ― 外資メガーバイオベンチャーで既存製品及び将来海外導入製品に向けてローカル規制に合わせた安全業務推進に幅広く携わりたい人 ー バイオ系製品においての安全性業務を幅広く経験積みたい人 ー 意思決定のスピード感が速く、革新的な技術をもっている企業 ー 柔軟的な働き方をしながら申請業務に携わりたい方（ハイブリッド勤務＋スーパーフレックスタイム制、コアタイムなし） Job Summary: As part of the Japan Safety organization, the Japan Safety PV Sr Associate is responsible for: Performing PV activities under the guidance of Japan Safety PV Sr Manager, Japan Safety PV Team Manager, or Japan Safety PV Manager: contributing to the local safety function in interactions with other functions within the company, staff members in Global Patient Safety, business partners and external health care professionals, to achieve Safety objectives; helping ensure compliant and efficient performance of local safety activities based on sound knowledge of local legislative requirements and practice, company policies and procedures; and participating in exchange of safety information with stakeholders （partners, and external; local, regional, and global） to support informed understanding of product safety issues. This position reports to Japan Safety PV Sr Manager, Japan Safety PV Manager, or Japan Safety PV Manager Key Activities Perform the following tasks, under the direction and guidance of the Japan Safety PV Sr Manager, Japan Safety PV Team Manager, and/or Japan Safety PV Manager: • General: － Execute safety （PV） processes for company products － Represent the Safety function on local product team（s） and joint product team（s） and Joint product teams（s） － Ensure safety compliance review and quality of safety part of CTN and NDA dossiers in Japan － Contribute to the creation and improvement of local business processes and system infrastructure for safety information collection and management • Safety Reporting and Safety Database: － Contribute to Safety Database conventions development and maintain current awareness of those conventions － Prepare the local periodic aggregate safety reports （e.g., J－DSUR, J－PBRER） － Perform assigned tasks ICSR handling workflow and the preparation of Japan－specific safety reports • Risk management and Risk communication: － Collaborate with cross－functional stakeholders on risk management planning and local risk minimization actions • Compliance and Regulatory: － Advocate safety compliance － Prepare for and participate in regulatory inspections by Regulatory Authorities • Training and Other Cross－functional Activities: － Train the company employees on safety reporting needs in Japan |
| 応募資格 |
【必須（MUST）】 － Experience in directly related to safety areas including PV regulations－ English language proficiency （business discussions, reading, and writing － General understanding of industry practices and standards － Experience with MS Word, Excel, PowerPoint, and Outlook － Master’s degree and 1 year of directly related experience OR Bachelor’s degree and 3 years of directly related experience |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/10/11 |
| 求人番号 | 3953755 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です