【R&D】Japan Patient Safety, Saftey Operational Excellence Dep. Safety External Relations, 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 ｾｰﾌﾃｨｴｸｽﾀｰﾅﾙﾘﾚｰｼｮﾝｽﾞｸﾞﾙｰﾌﾟ

■ 職務内容 / Job Description

Safety External Relations Group is responsible for:
・Work for management of PV related operational activities by external relations by ensuring effective working business model with external relations incl. way of working, communication flamework, procedures etc.
・Manage budget and cost for external vendors
・Manage operational activities for Clinical Experience Investigation (CEI) and Specific   Experience Investigation (S-CEI) by collaborating with vendors
・Manage operational activities for Early Post-marketing Phase Vigilance (EPPV) by collaborating with sales department
・Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance

■ 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
・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