求人番号:129798
多数の革新的な製品を有する外資系バイオ製薬企業
Patient Safety(ファーマコビジランス)【アソシエイトディレクター~ディレクター】:外資系バイオ製薬企業!
- 業種
- 製薬メーカー
- 職種
- PV(安全性監視)・PMS(市販後調査)
- 年収
- 1,300万円~1,900万円
- 勤務地
- 東京都
外資系企業
管理職・マネージャー
海外折衝
英語力が必要
転勤なし
土日祝休み
リモートワーク可
- 仕事内容:
- ・Serves as or contributes to a lead member of the J-PS, in developing content and strategy.
・Provides support to J-PS Senior Director directly
・Oversees and ensures successful completion of all assigned activities and projects.
・Well understands all activities and projects performed in multiple therapeutic areas.
・Leads assigned topics and/or reviews: literature for ICSRs and other report types including Foreign Safety Measure report criteria and Japan Research Report criteria.
・Complies with all regulatory requirements of Pharmacovigilance regulations globally from competent authorities; maintains confidentiality; meets all safety reporting deadlines.
・Signal detection and authorship of signal work-up documents in collaboration with relevant contact at global Therapeutic Areas members.
・Appropriate input and support for safety descriptions in Japanese Package Insert (J-PI) and associated supporting documentation.