【AstraZeneca】【R&D】セーフティストラテジーリード(オンコロジー領域), ペ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