Senior GSPV associate~GSPV AssociateⅡ(Global Safety & Pharmacovigilance)の求人情報なら転職エージェントJAC

求人情報

Senior GSPV associate~GSPV AssociateⅡ(Global Safety & Pharmacovigilance)

  • 転勤なし
  • 週休二日制
  • 外資
求人番号

NJB1024335

[無料]転職サポートのお申し込み

会社名 インヴェンティヴ・ヘルス・ジャパン合同会社 <業種:メディカル・バイオ - CSO>
職種

メディカル・バイオ-安全性情報(臨床開発/製販後GVP)

雇用形態 正社員(期間の定めなし)
勤務地 大阪府 東京都
仕事内容

GSPV AssociateⅡ

【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 Pr

……(以下詳細は面談時にご案内します)


■休日:完全週休二日制 年末年始

求める経験、能力
年齢制限の理由

<GSPV AssociateⅡ>

・2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(未経験の場合は必須)

Education Required:

Bachelor’s degree, preferably in a life science, nursing, pharmacy and two years of relevant with at least two years of safety/PV 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%)

<Senior GSPV associate>

・科学系もしくは看護系学位

・3年以上の安全性業務経験(プラス臨床開発経験は尚可)

・業務遂行上必要なレベルの英語力

・システム経験(アーガス・E2Bは尚可)

-Bachelor’s Degree in a life science or nursing

-Five years of experience with clinical trials, may include data management, CRA, clinical practice (RN, RPN), health authority or study coordinator experience

-Three years of Safety/Pharmacovigilance experience

-Excellent verbal and written communication skills, including business level English (reading/writing)

-Experience with safety database systems: Perceive, E2B Writer, Clinical Works, ARISg or Argus preferred

-Ability to work as part of a team and across geographical locations

-Possesses a positive attitude and works well with others


■職種未経験者:不可

年収 400万円 - 900万円
語学力
英語力: 
中級

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