大手外資CSOでのGSPV Associate�(Global Safety & Pharmacovigilance)【経験者】の求人

【主たる業務】
・国内外症例の入力業務及びQC
・法令及びコンプライアンスチェック
・ナラティブを含む症例入力、重篤等に関する一次評価
・症例に関するクエリ（再調査質問票）作成
・MR及びCRAとの症例／クエリに関するコミュニケーション
・社内外プロジェクト参加者との協業
・ファイリング及び症例ストレージ
・SOP及び法令に関するコンプライアンスチェック
・社内外関係者との安全性情報に関する情報共有
・国内外へのミーティング参加、監査への参加
・アシスタントや通訳等に対するメンタリング

【Primary Function】
The position is responsible for the processing and review of AS/SAE information received from sites for completeness and regulatory compliance.

【Major responsibilities】
・Process adverse event reports received from sites/reporters
・Perform QC review of completed individual and periodic safety reports
・Complete data entry including writing od adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information
・Generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information on the sites/reporter
・Engage with site monitors to ensure follow up information is obtained from site effectively
・Foster contractive and professional working relationships with all project team members with all project team members, internal and external
・File documents according to project specific requirements (electronically or in hard copy as applicable)
・Ensure case files are compliant with SOPs.
・Distribute safety data reports to other Safety Associate peer and Medical Monitor for review
・Distribute safety data reports to clients and other relevant parties
・Ensure compliance with company policies, procedures, and standards
・Participate in audits as required/appropriate
・Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects
・Mentor or train less experienced Safety Associates on processes regarding case management
・Perform literature review as appropriate for Post-Marketing cases
・Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting
・Any other duties as assigned by manager

Responsible for performing activities that are in compliance with applicable Corporate and Division Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

・1年以上の安全性業務経験
・安全性業務1年を含む3年以上の業界経験
・システム経験（アーガス・E2Bは尚可）
・PC操作に関する基本的な知識
・科学系もしくは看護系学位は尚可

【Education Required】
・Bachelor’s degree, preferably in a life science, nursing, pharmacy and two years of relevant with one year of safety/PV experience. Relevant experience could include data management, CRA, clinical practice, regulatory authotiry, or study coordinator experience
・In lieu of degree or healthcare professional license/certification, a total of three years safety/PV experience may be considered

Minimum Training & Experience required
・Familiarity with safety database systems: ARISg or Argus preferred
・Ability to successfully prioritize and work on multiple tasks
・Excellent team player and attention to detail
・Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
・Excellent knowledge of ICH guidelines and regulations relating to safety reporting
・Computer proficient including experience with Microsoft Office Suite, including but not limited to Word processing software(MS WORD), presentation　software (MS Powerpoint), email software(Outlook), diagramming/workflow software (MS Visio), and spreadsheet software ( MS Excel).
・Ability to travel as necessary (less than 5%)