募集要項
- 募集背景
- 戦力強化のため。
- 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.
- ポジション
- 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】
- 応募条件
-
■求める学歴
・Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level.
■求める経験
【Desirable】
・Extensive experience (5+ years, preferred) in pharmacovigilance/PMS (Oncology therapeutic area) is required.
※安全性業務の実務を熟知、俯瞰し、戦略的・実践的なチームビルドができる方。
■マネジメント経験
不要
- 必要スキル
-
■求める英語レベル
ビジネス会話レベル
■求める英語レベル詳細
・ビジネスレベルの英語力
■必要スキル
・Excellent knowledge of pharmacovigilance regulations aggregate safety reports, internal risk management plans, signal detection, clinical trials, and clinical development.
・Demonstrates ability to assess complex data sets and understand the safety/medical implications.
・Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies.
■ITスキル
・Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point.
- 求める人物像
-
・Demonstrates excellent attention to detail, teamwork, and initiative; maintains confidentiality; maintains meticulous attention to project deadlines.
・Demonstrates ability to influence others at the same or more junior levels within the organization.
- 雇用形態
-
正社員
- 転勤
-
無
- 勤務地
-
東京本社
- 勤務時間
-
9:00～18:00 フレックス制度あり
- 年収
-
1,300万円～1,900万円
- 休日休暇
-
完全週休2日制（土、日）、祝日、年間休日数125日、有給休暇、年末年始、慶弔休暇
- 福利厚生
-
健康保険、厚生年金保険、雇用保険、労災保険、退職金制度、確定拠出年金制度、ベネフィットステーション
- 受動喫煙防止措置
-
事業所内禁煙
- 担当者メッセージ
-
多数の革新的な製品を有する外資系バイオ製薬企業で、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】職を募集いたします！
安全性業務の実務を熟知、俯瞰し、戦略的・実践的なチームビルドができる方を求めております。
ご応募をお待ちしています。
