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【AstraZeneca】【R&D】Safety Evidence Lead, 研究開発本部 ペイシェント セ-フティー統括部 セーフティエビデンスジェネレーション部

Location Osaka, Ōsaka, Japan Kita-ku, Tokyo, Japan Job ID R-186944 Date posted 07/04/2024

■ 職務内容 / Job Description

The Safety Evidence Lead (SEL) is responsible for generating post-marketing safety evidence of products including regulatory mandatory Post Marketing Studies and Pharmacovigilance (PV) activities using real-world data in Japan. The SEL is responsible for leading creation of Japan Periodic Safety Updated Report (J-PSUR) and Re-examination submission dossier, excluding the surveillance parts. 

- Has accountability for additional Pharmacovigilance Plan(aPVP) including Post Marketing Surveillance(PMS) and Database (DB) research of an assigned product(s) in Japan as a member of Japan Pharmacovigilance Team(J-PVT).  
- Leads assigned study team, a sub-team of J-PVT to deliver the study(ies) according to the plan.  
- Lead to develop aPVP and study protocol based on safety related question(s). 
- Develops and maintains study protocol and relevant part of J-RMP in collaboration with cross-functional members in Japan, Global Patient  Safety such as Safety epidemiologist and ERT/MARC in compliance with GVP/GPSP and relevant AZ SOPs.  
- Creates study report, J-PSUR and Re-examination dossier excluding surveillance parts in collaboration with relevant members. 
- Leads publication(s) for implemented study(ies). 
- Develops and Implement the evaluation of risk minimization plans to assure patient safety consistently throughout product life cycle in collaboration with J-PVT members.   
- Provide scientific guidance for continuous improvement of study design, fashion and process in terms of pharmacoepidemiology and pharmacovigilance 
- Ensures right quality of PMS/DB research related deliverables such as study protocol, statistical analysis plan and study report.  
- Escalates any actual/potential compliance issue to relevant operational bodies to support for solving it. 
- 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.  
- 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.)

【経験 / Experience

<必須 / Mandatory>

- Minimum of 1 year, preferably more than 3 years of experience in clinical trials, health research, risk management plan, PMS or post-marketing surveillance-related roles in pharmaceutical companies, academia, CROs, or regulatory agencies.

- Cross-functional project team experience
- Proven leadership and program management experience 

<歓迎 / Nice to have>

- Experience in epidemiological research or data analysis in safety-related fields using real-world data (RWD) such as claim or EHR databases.

- Hands-on experience in handling and analyzing real-world data with statistical software.  
- Working with external parties, such as technical or medical experts and advisory board members, as a leading person 
- Practical experience in epidemiological research or academic training outside Japan

【資格 / License

<必須 / Mandatory>

- Bachelor Degree in Science or related discipline

<歓迎 / Nice to have>

- Advanced science degree in epidemiology, biostatistics or public health(Ph.D., MPH, MS etc.) or equivalent educational certifications

【能力 / Skill-set

<必須 / Mandatory>

Leadership & Communication
Basic knowledge of health research methods, epidemiology, and biostatistics.

High motivation for acquiring skills to produce better Real-World Evidence (RWE).
Project & stakeholder management
Relevant regulations such as GVP/GPSP

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 
Ethics – overriding commitment to integrity and high standards in self and others 
(for Career level E) 
Coaching & mentoring 
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 

<歓迎 / Nice to have>

Programming(e.g., R, Stata, Python, or SQL)
Medical writing & scientific publication

【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】


【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 authorization and employment eligibility verification requirements.

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