【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
■ 職務内容 / Job Description
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】
<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】
D or E
【勤務地 / Work Location】
Osaka or Tokyo