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.

Accountabilities/Responsibilities:
- 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.
(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.
- 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 】

Minimum of 3 years' experience in clinical trials, health research, or post-marketing surveillance-related roles in pharmaceutical companies, academia, CROs, or regulatory agencies.

Experience in epidemiological research or data analysis in safety-related fields using real-world data (RWD) such as claim or EHR databases.
- Cross-functional project team experience
- Proven leadership and program management experience

Hands-on experience in handling and analizing 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 】

Bachelor Degree in Science or related discipline

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

【能力 / Skill-set 】

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

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

【語学 / Language 】

日本語 Japanese:ネイティブ

英語 English Business English Level

【語学 / Language】

日本語 Japanese:ネイティブ

英語 English Business English Level

【キャリアレベル / Career Level】

D or E

【勤務地 / Work Location】

Osaka or Tokyo

Date Posted

12-12月-2023

Closing Date

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