大手外資CSOでのSenior GSPV associate(Global Safety & Pharmacovigilance) 【経験者】の求人
求人ID:105874
募集終了
転職求人情報
職種
Global Safety & Pharmacovigilance
ポジション
シニア・アソシエイト
おすすめ年齢
20代
30代
40代
50代以上
年収イメージ
400万円〜900万円(諸手当など別途支給、業績により業績賞与支給あり、経験・能力により応相談)
仕事内容
【主たる業務】
国内外症例の評価入力、法令に基づくPMDA提出書類の作成
・施設及び海外データベース上の症例の評価入力及びQC
・症例に関するプロセス全体の把握及び管理
・公式報告書及びE2Bファイルの管理作成
・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
・国内外へのミーティング参加、監査対応
・アソシエイトに対するメンタリング等
【Primary Function】
This position is responsible for processing and reviewing AE/SAE information in domestic and overseas safety cases received from Manufacturing Authorization Holders (MAHs), medical institutions, and regulatory authorities for completeness and regulatory compliance.
【Major responsibilities】
-Process adverse event case information received from medical sites/reporters, and MAHs
-Perform quality control review of completed individual cases and periodic safety reports
-Complete pre-intake, triage, assessment, validation, finalization, and translations including writing of adverse event narrative and provide the final assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information
-Prepare ADR reports and E2B files for regulatory submission
-Generate adverse event queries, liaise with the medical reviewers/the MAH to agree upon the queries, and send request for additional information to the sites/reporter
-Engage with the Site Monitors and MRs to ensure follow-up information is obtained from medical institutions effectively
-Foster constructive and professional working relationships with all project team members, internal and external
-File documents report results, and store records according to project specific requirements (electronically or in hard copy as applicable)
-Ensure safety management activities are compliant with SOPs and regulations
-Distribute safety date reports to team members for medical assessments and reviews
-Distribute safety data reports to Safety Managers, the MAH, and other relevant parties
-Responsible for ensuring project deliverables are completed on time and with high quality
-Participate in the development of safety SOPs and Operating Guides
-Participate in project meetings with local and global GS&PV team members as required
-Participate in audits as required/appropriate
-Mentor and train other associates on procedures regarding case processing
-Perform literature review as appropriate for clinical and Post-Marketing cases
-Maintain knowledge of all applicable guidelines and regulations relating to safety and PV reporting
-Any other duties as assigned by Safety Managers
国内外症例の評価入力、法令に基づくPMDA提出書類の作成
・施設及び海外データベース上の症例の評価入力及びQC
・症例に関するプロセス全体の把握及び管理
・公式報告書及びE2Bファイルの管理作成
・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
・国内外へのミーティング参加、監査対応
・アソシエイトに対するメンタリング等
【Primary Function】
This position is responsible for processing and reviewing AE/SAE information in domestic and overseas safety cases received from Manufacturing Authorization Holders (MAHs), medical institutions, and regulatory authorities for completeness and regulatory compliance.
【Major responsibilities】
-Process adverse event case information received from medical sites/reporters, and MAHs
-Perform quality control review of completed individual cases and periodic safety reports
-Complete pre-intake, triage, assessment, validation, finalization, and translations including writing of adverse event narrative and provide the final assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information
-Prepare ADR reports and E2B files for regulatory submission
-Generate adverse event queries, liaise with the medical reviewers/the MAH to agree upon the queries, and send request for additional information to the sites/reporter
-Engage with the Site Monitors and MRs to ensure follow-up information is obtained from medical institutions effectively
-Foster constructive and professional working relationships with all project team members, internal and external
-File documents report results, and store records according to project specific requirements (electronically or in hard copy as applicable)
-Ensure safety management activities are compliant with SOPs and regulations
-Distribute safety date reports to team members for medical assessments and reviews
-Distribute safety data reports to Safety Managers, the MAH, and other relevant parties
-Responsible for ensuring project deliverables are completed on time and with high quality
-Participate in the development of safety SOPs and Operating Guides
-Participate in project meetings with local and global GS&PV team members as required
-Participate in audits as required/appropriate
-Mentor and train other associates on procedures regarding case processing
-Perform literature review as appropriate for clinical and Post-Marketing cases
-Maintain knowledge of all applicable guidelines and regulations relating to safety and PV reporting
-Any other duties as assigned by Safety Managers
必要スキル
・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
・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
就業場所
就業形態
正社員
企業名
大手外資CSO
企業概要
大手外資CSO
企業PR
組織カテゴリ
備考
関連キーワード
その他(事業会社)の求人情報
事業会社の求人情報
グローバルの求人情報
転職体験記
- 希望退職に応じた末の再就職、ヘルスケア系上場ベンチャーへ(50代/男性/私立大学卒)
- 日系SIerから大手携帯電話通信キャリアへ(30代/男性/私立大学卒)
- 機械メーカーを定年退職後の再就職、地方銀行へ(60代/男性/国立大学院卒)
- 金融業界での経験を活かして、投資運用会社へ(60代/男性/国立大学卒)
- 損害保険会社でのコンプライアンス業務に専念すべく転職を決意(30代/女性/私立大学卒)
- グローバル企業での経験を活かしつつ新たなチャレンジ、有名チェーン店等を運営する外食企業へ(30代/男性/私立大学卒)
- 物流業界へのこだわり、大手商社設立の食品EC企業へ(40代/男性/私立大学卒)
- 2回目の転職も同じコンサルタントで、大手日系信託銀行へ(40代/男性/私立大学卒)
- 大きな可能性を感じられる企業へ転職、損害保険会社へ(40代/女性/国立大学院卒)