【AstraZeneca】【R&D】ｾｰﾌﾃｨｽﾄﾗﾃｼﾞｰﾘｰﾄﾞ(ｵﾝｺﾛｼﾞｰ領域), ﾍﾟｲｼｪﾝﾄｾｰﾌﾃｨ統括部

■ 職務内容 / Job Description

Description:

(Common)

The Safety Strategy Lead (SSL) is responsible for planning Japan Risk Management Plan (J-RMP) and leading the execution of Pharmacovigilance (PV) activities excluding Post Marketing Surveillance (PMS) studies of assigned product(s) throughout the entire product’s life cycle.

(For career level D&E)

 The SSL can be assigned as a leader of Japan Pharmacovigilance Team (J-PVT), a sub-team of Japan Project Team (JPT) and be accountable for PV strategy of the product(s) in Japan.

Accountabilities/Responsibilities:

• Develops and maintains J-RMP, JPI safety part and relevant documents in cross functional team with full consideration of the latest information and in compliance with GVP/GPSP and relevant AZ SOPs.
• Creates the protocol and report of Early Post-marketing Phase Vigilance (EPPV).
• Implements the optimal safety surveillance of the product in consideration of the safety profile of product(s) specifically required for Japan regulation.
• Coordinate required data output from safety database to support communication with external stakeholders in Japan.
• Coordinate transition of required safety data and regulatory mandatory documents associated with MAH transfer.
• Ensures right quality of PV related deliverables such as J-RMP, EPPV reports, etc.
• Escalates any actual/potential compliance issue to relevant operational bodies to support for solving it.

(For career level D&E)

• Has accountability for PV activities of an assigned product in Japan as a representative of J-PVT.
• Leads and manages J-PVT to enable and drive PV delivery according to plan including budget and timeline.
• Leads to develop strategy and options for PV plan of the product as a J-PVT leader, in collaboration with JPT and Safety Strategic Management Team (SSaMT).
• Lead response to regulatory queries for post-marketing safety matters in collaboration with relevant functions including Global Patient Safety.
• Ensures governance and key stakeholder engagement is effectively managed.

(For career Level E)

• Leads and coaches the other members working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
• Proactively contributes to performance development of the other members working on the product/project in collaboration with Line Managers.
• Provides leadership as needed in the issue management such as compliance issue, Blue/Yellow letter delivery or product recall for safety issue and in the co-promotion business agreement.
• Provide leadership as needed in the non-product cross-functional initiative for organizational capability development.

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

Education

• Bachelor’s or higher Degree in Science or related discipline

Required Experience

• Relevant safety experience in Pharmaceutical industry

(For career level D&E)

• Cross-functional project team experience

(For career level E)

• Demonstrated experience in achievement of safety management, drug development or launch
• Proven leadership and program management experience

Preferred Experience

• 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

Skills and Capabilities

(Common)

• Understanding of relevant regulations such as GVP/GPSP
• Thorough knowledge of the Pharmacovigilance and/or drug development process
• Scientific knowledge sufficient to understand all aspects of safety issues
• Logical thinking
• Assertive Communication/negotiation skill
• Problem solution skill
• Analytical Thinking - Logically breaking situations or issues down into their essential elements; carrying out diagnosis and developing solutions.
• Results Focused – ability to overcome obstacles and achieve key outcomes
• Ethics – overriding commitment to integrity and high standards in self and others
• Basic IT skill
• Business English (Speaking level 6 or above)
• Fluent in Japanese

(For career level D&E)

• Leadership skill
• Project Management skill
• Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas

(For Career level E)

• Coaching & mentoring 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
• Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas
• Cultural Awareness – able to work successfully in a multi-cultural environment

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：ネイティブ

英語 English：Business English Level

【キャリアレベル / Career Level】

C/D/E

【勤務地 / Work Location】

Osaka or Tokyo 

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.