Saftey Operational Excellence Dep. Safety Process

安全情報の収集を担当するメンバー（営業担当者、CRA、CROなど）へのトレーニングの実施

仕事内容

Safety Process Group is responsible for:
・Deliver training to the members who are responsible for collecting safety information (e.g. sales reps, CRAs, CROs)
・ Support creation of safety information exchange/collection process with relevant parties to facilitate comprehensive and speedy safety data exchange/collection (e.g. global interface organization, safety science, licensees/licensors, clinical study team, medical affairs)
・Support to create and implement case handling process that addresses to the product specific local RMPs if needed
・Ensure safety information (Marketed drug: ICSR; Investigational medicinal product: ICSR, research report, measures taken report, annual report) is submitted without delay to the relevant parties (Regulatory authority, License partners, Clinical Operation, Collaboration partners)
・Accommodate changes of the regulatory requirements and critical business needs
・ Lead planning and execution of training activities with an appropriate network such as functional training coordinators, or other department members
・Lead activities to establish and maintain the framework to ensure an appropriate document recording and archiving
・Self-inspection responsible person: To enhance quality management in both GVP/GPSP control unit and operation unit through self-inspection activities to secure pharmacovigilance activities in compliance with the appropriate standards such as GVP/GPSP
・Contract responsible person: To secure appropriate documentation of safety agreements (mainly GVP/GPSP contract)
・Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance
・Collaborate with relevant functions across Global and Japan organizations

応募条件

【必須事項】

・Bachelor’s Degree in Science or related discipline
・ Relevant Pharmacovigilance experience in pharmaceutical industry
・Comprehensive understanding of Pharmacovigilance regulatory requirements and business needs
・ Cross-functional project team member experience
・Communication/negotiation skill
・Leadership skill
・Problem solution skill
・Logical thinking
・Business English (Speaking level 6 or above)
・Understanding of PMD Act, relevant regulations, GCP/GVP/GPSP and guidelines
・Basic knowledge of statistic analysis
・Expertise of medical/pharmaceutical science in general
・英語 English： Business English (Speaking level 6 or above)

【歓迎経験】

・Pharmacovigilance activities, drug development or regulatory affairs experience in/outside Japan
・Working with external bodies such as outsourced vendors and co-development companies as a leading person
・Cross-functional project team leader/member experience

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

在宅可、大阪、東京

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：125
土日祝
年間有給休暇：入社半年経過時点12日（入社月に応じて4日～最高20日）　 ～ 20日
法定休暇：年次有給休暇、産前産後休暇
その他休暇：リフレッシュ休暇、頭痛休暇他

年収・給与

経験により応相談

諸手当

住宅手当、通勤手当、単身赴任手当、休日手当ほか

昇給

年１回

賞与

年間標準6ヶ月

採用人数

1名　

待遇・福利厚生

通勤手当：有
確定拠出年金、財形貯蓄制度・持株会制度・慶弔見舞金・健康診断・福利厚生倶楽部ほか

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
退職金制度：有

選考プロセス

１）書類選考
２）一次面接
３）最終面接