【AstraZeneca】【R&D】Japan Patient Safety, Saftey Operational Excellence Dep. Safety Process, ﾍﾟｲｼｪﾝﾄｾｰﾌﾃｨ統括部 ｾｰﾌﾃｨｵﾍﾟﾚｰｼｮﾅﾙｴｸｾﾚﾝｽ部 ｾｰﾌﾃｨﾌﾟﾛｾｽｸﾞﾙｰﾌﾟ

■ 職務内容 / Job Description

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 AZ organizations

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

・ Relevant Pharmacovigilance experience in pharmaceutical industry
・Comprehensive understanding of Pharmacovigilance regulatory requirements and business needs
・ Cross-functional project team member experience

＜歓迎 / Nice to have＞

・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

【資格 / License】

＜必須 / Mandatory＞

Bachelor’s Degree in Science or related discipline

【能力 / Skill-set】

＜必須 / Mandatory＞

・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

【語学 / Language】

＜必須 / Mandatory＞

英語 English： Business English (Speaking level 6 or above)

【キャリアレベル / Career Level】

C/D/E

【勤務地 / Work Location】

Osaka or Tokyo