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【R&D】 Safety Product Lead, R&D SDA セーフティプロダクトリード部

Location Osaka, Ōsaka, Japan Kita-ku, Tokyo, Japan Job ID R-139637 Date posted 30/06/2022

■ 職務内容 / Job Description

Safety Product Lead is a cross-functional leader of Japan Pharmacovigilance Team (J-PVT), a sub-team of Japan Project Team (JPT). The Safety Product Lead is responsible for overall pharmacovigilance plan of assigned product(s) in Japan to optimize benefit-risk balance of the product(s) and has accountability for quality of deliverables related to pharmacovigilance (PV) activities (e.g. EPPV, PMS, Re-examination) throughout the entire product’s life cycle. SPL's key accountability & responsibility are:
╸Has overall accountability of PV activities of assigned product as a representative of the J-PVT.
╸Leads to develop strategy and options for overall pharmacovigilance plan of the responsible product with quality in J-PVT, in collaboration with JPT and Safety Strategic Management Team (SSaMT).
╸Has accountability of developing/maintaining Japan Risk Management Plan (J-RMP) and its relevant documents in cross functional team with full consideration of the latest information.
╸Leads and manages the J-PVT to enable and drive PV delivery according to plan. ╸Ensures right quality of PV related deliverables such as J-RMP, EPPV/PMS reports, J-PSUR, Re-examination package, etc.
╸Ensures governance and key stakeholder engagement is effectively managed.
╸Leads Re-examination Team to submit re-examination package according to plan.

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

<必須 / Mandatory>

• Cross-functional project team experience
• Proven leadership and program management experience
• Scientific knowledge sufficient to understand all aspects of safety issues
• Thorough knowledge of the Pharmacovigilance and/or drug development process
• Demonstrated experience in achievement of safety management, drug development or launch

<歓迎 / Nice to have>

• PMDA/MHLW interactions as a leading person on safety related matters/drug development/regulatory issue
• Pharmacovigilance activities, Drug development or regulatory affairs experience in outside of Japan
• Working with external bodies, such as co-marketing companies and advisory board members, as a leading person

【資格 / License】
<必須 / Mandatory>

Bachelor’s Degree in Science or related discipline

【能力 / Skill-set】
<必須 / Mandatory>

• Leadership skill
• Project Management skill
• Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions.
• Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
• Logical thinking
• Problem solution skill
• Understanding of relevant regulations such as GVP/GPSP
• Expertise of medical/pharmaceutical science in general

<歓迎 / Nice to have>

• Results Focused – ability to overcome obstacles and achieve key outcomes
• Cultural Awareness – able to work successfully in a multi-cultural environment
• Analytical Thinking - Logically breaking situations or issues down into their essential elements; carrying out diagnosis and developing solutions.
• Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
• Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas
• Ethics – overriding commitment to integrity and high standards in self and others
• Coaching & mentoring

【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】
D or E

【勤務地 / Work Location】

Osaka or Tokyo

50056666 E CDPG R&D Oncology

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.