社名
社名非公開
職種
マーケティング、調査、マーケティングコミュニケーション、広報(PR)
業務内容
製品の製造販売承認審査において規制当局と検討、合意した製造販売後調査等の企画立案とその実行、また結果の規制当局への報告を主な責務としています。製品担当責任者として、担当製品の製造販売後調査等(PMS)の企画立案、実施結果の確認、規制当局提出書類の作成・報告及びそれらの管理（プロジェクトマネジメント）が主な業務です。具体的には以下のような業務を担当していただきます。・治験時の状況や医薬品リスク管理計画書の安全性検討事項並びに承認審査時の課題等に基づく製品プロファイルに応じた適切なPMS（使用成績調査、データベース調査、製造販売後臨床試験）の企画立案• Study Outline、実施計画書、調査票などの作成及びGlobal approvalの取得•解析計画の立案、解析結果の評価 とCSRの作成•安全性定期報告書、再審査申請資料の作成•再審査申請適合性調査への対応•規制当局との折衝、照会事項の回答及び各種規制当局相談の対応•その他製造販売後調査等に関連する課題解決への対応
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pms planning and medical writing manager：外資製薬会社.
- posted 10 june 2024
- closes 30 december 2024
experience
・薬機法やGPSPに関する基礎的な知識又はGxP領域での業務経験 3年以上 ・読み書きレベルの英語力
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