安全管理責任者

【求人No NJB2346093】
本ポジションは、製品の安全性と有効性を担保するため、国内外の規制対応と安全管理を統括します。
安全管理責任者として、医薬品安全監視システムの構築・維持、報告義務の遵守、リスク管理、教育訓練の実施を行います。添付文書の作成・改訂や、外部安全管理委託先の監督も担当。製品登録申請や承認取得、開発プロジェクト支援、グローバルデータベースの活用、内部監査のリードも含まれ、チームと連携し事業目標達成に貢献します。

■Person Specification （Experience Academics Organizational Knowledge Personal Style）
〇Experience Academics
・ 3+ years of experience in Pharmacovigilance of Pharmaceuticals in a multinational company
・ General Knowledge of PMD Act. GVP MHLW Ordinance ICH and relevant regulations
・ Experience in English business communication
・ Communication with governmental bodies

〇Organizational Knowledge
・ Understand the company systems and processes ・ QA QC Marketing Sales Customer service IT HR GA Finance Manufacturing Supply chain
・ Ability to communicate effectively across all operational levels of the organization as well as with suppliers and customers exercising appropriate tact and diplomacy to accomplish objectives
・ Effective interpersonal skills with the ability to present recommendations and ideas and to summarize issues
・ Strong interpersonal communication and analytical skills
・ Ability to work independently

〇Personal Style
・ Take the initiative Leadership to achieve goals
・ Coordinate closely with concerned parties （internal and external）
・ Hear other opinions and get mutual consent
・ Positive and logical thinking
・ Stay calm in any trouble case

■COMPETENCIES REQUIRED
〇Behavioral Competencies
・ Communication / Presentation / Negotiation / Influential skills （Japanese / English）
・ Inter functional leadership skills and team player
・ Problem analysis and solving skills
・ Strategic thinking and planning
・ Sound judgement ・ Attention to detail
・ Customer oriented ・ Spontaneity
・ Cross cultural communication skill
・ Team Building skill

〇Functional Competencies
・ Ability to understand internal/external customer technologies and problem resolution techniques.
・ Ability to communicate effectively with customers
・ Ability to listen to symptom descriptions; to analyse problems; to respond effectively and to provide constructive feedback to the customer on problem resolution
・ Grasp overview of business project
・ Business market awareness
・ Negotiation Skills