募集要項
- 仕事内容
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『Clinical Safety Sr. Specialist』
■Job Summary
Clinical Safety Sr. Specialist will work under the direction of the Senior Manager, Clinical Event Reporting, US, processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects in accordance to reporting requirements.
■ROLL & RESPONSIBILITIES
＊ Assesses adverse event reports and analysis for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited UADEs, aggregate reports and other regulatory documents as requested)
＊ Processes all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting
＊ Contribute to Safety sections of protocol design, submissions, reports, clinical summaries (as needed)
他
- 応募資格
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- 必須
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■ At least 3-5 years of global industry experience with device/drug safety is required, RN or similar experience .
■ Knowledge of global safety regulations, principles of device development and safety assessment of devices both on the market and in clinical development is required.
■ Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally is required.
■ Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards.
■ Proficient in MS Office and database navigation skills.
■ Strong interpersonal and communication skills both in English, Japanese.
■ Highly motivated and capable of working independently and as a team member.
■ Strong technical writing skills both in English, Japanese.
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 勤務時間
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9:00～17:00（休憩12:00～13:00）
- 年収・給与
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想定年収 ： １４４０万円～1680万円
- 待遇・福利厚生
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■各種社会保険完備
■退職金制度（確定拠出年金、確定給付年金）
■財形貯蓄
■従業員持株制度
■団体総合生命保険
■カフェテリアプラン
■優秀セールス表彰制度
■永年勤続表彰制度
■転勤者に対する借上社宅
- 休日休暇
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■週休2日制（土日）
■祝日
■年末年始
■夏期有給休暇（5日間）
■年次有給休暇（初年度10日）
■慶弔
■産前産後休暇
■転勤休暇
■育児休業
■介護休業
