外資系大手製薬メーカー　【R&D】Safety Physician, ﾍﾟｲｼｪﾝﾄ ｾ-ﾌﾃｨ統括部 ﾍﾟｲｼｪﾝﾄｾｰﾌﾃｨ ｽﾄﾗﾃｼﾞｰｵﾝｺﾛｼﾞｰ部

資格・要件

経験 Experience
<必須 Mandatory>
5年以上の医師としての臨床経験
<歓迎 Nice to have>
臨床試験、臨床研究、疫学調査などの経験
製薬会社での業務経験
資格 License
<必須 Mandatory>
日本の医師免許
<歓迎 Nice to have>
専門医、指導医、PhD
能力 Skill-set
<必須 Mandatory>
戦略的影響力: 十分に考え抜かれた根拠と効果的なコミュニケーションスキルを通じて、重要な意思決定に影響を与えられる。
コミュニケーションスキル: いつ、どのように伝えるべきかを理解し、必要に応じて優れた対人スキルや文章力を用いて情報を伝達できる。
結果志向: 障害を乗り越え、重要な成果を達成する能力がある。
コミットメントの獲得能力: 対人能力を効果的に活用して関係を構築し、アイデアの受容を得ることができる。
効果的なパートナーシップ構築: 機会を見出し、チーム内および他部門との有効な関係構築に向けて行動する。
倫理観: 自身と他者において、誠実さと高い基準を最優先で貫く。
<歓迎 Nice to have>
文化的感受性: 多文化環境で成功裏に業務を進めることができる。
分析的思考: 物事や課題を論理的に本質要素へ分解し、診断を行ったうえで解決策を策定する。
語学 Languages
<必須 Mandatory>
Native Japanese
Business English (Globalとの会議でDiscussionが可能なレベル)

職務内容

Job Description

Pre-/Launch Enablement
Support cross-functional product launch team to establish and implement a safety launch plan to ensure the PS system and organization’s readiness for new products or new indication launches.
Responsible for providing safety input and support to medical and brand team activities, including the development of safety strategy, support product launch planning, contribution to regulatory submissions and product labeling activities, and accountable for PS specific documents such as periodic safety reports or regulatory responses as appropriate.
Contributes to the content of the Safety Sections of the local Prescribing Information for assigned products
Routine Safety Surveillance and Issue Management

Accountable for patient safety surveillance activities, and for providing medical leadership as a safety expert for assigned products/assigned therapeutic area(s) (TA).
Support safety team and other PS functional teams as appropriate for products to ensure delivery of PS activities to optimize patients’ benefit-risk profile and to ensure AZ’s license to operate.
Responsible for local surveillance activities including post-marketing safety evaluations and timely escalation of newly identified safety issues to appropriate stakeholders. Collaborate with GPS and other functional teams to address identified safety issues, if necessary.
Contributes to local product benefit/risk assessment, risk management, risk mitigation, and risk communications.
Contributes Patient Safety expertise and input into local Safety Issue management and Health Hazard Evaluation as appropriate.
Governance, Compliance, and Regulatory Interface

The PS Physician is a medical specialist accountable for medical appropriateness with local regulatory requirements and deliverables for PS activities, in accordance with AstraZeneca and Alexion (hereafter, AZ) product strategy.
Ensure that all work is carried out with regards to AstraZeneca standards and external regulations, closely collaborates with other relevant stakeholders in the global and local business (including regulatory, medical affairs, marketing, etc.).
PS physician ensures the medical accuracy and quality in the local language in accordance with local medical practice and relevant legislation for pharmacovigilance activities (L-PI, L-RMP, PMS, PSUR, Individual Case Safety report)
Responsible for strategy, content, and development of local-specific periodic safety reports and contribution to correspondence to PMDA's safety queries to secure regulatory timelines.
Provides Patient Safety expertise and contributions to the development of local regulatory response documents.
Medical Leadership and Knowledge Development

Lead safety medical science to ensure the medical quality of safety measures at the local country level.
Develop and improve the medical knowledge of the local Patient safety team by giving adequate opportunities for medical training.
Organize the medical training program to raise the staff’s medical knowledge.
Lead the discussion with KEEs in safety advisory board meetings.
Strategy and Cross-Functional Collaboration

Promote local PS safety strategies & provide the necessary support for its implementation.
The PS Physician promotes the safety of patients who receive AstraZeneca products, to optimize overall benefit/risk in the local market.
Ensure effective collaboration with stakeholders in cross-functional teams.
Provides PS input as appropriate to global governance teams (i.e., SIRC, ERT/MARC) and bridges local market with Global PS in decision-making processes.
Closely collaborates with other relevant internal stakeholders in the global and local business functions (including regulatory, medical affairs, marketing, etc.).
External Engagement and Representation

Represents AstraZeneca and Patient Safety at external professional events, and networks with peers and external experts.
Networks with external or internal colleagues and experts, provides consultancy in own area of expertise, and serves as a resource for others by sharing experience within and beyond project team and function.
Provides litigation safety support upon request.

【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:15
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇　初年度12日
年間休日日数121日
【将来的に従事する可能性のある職務内容】会社の定める職務
＜将来的に勤務する可能性のある場所＞会社の定める事業拠点（テレワークを行う場所を含む）
■公休日：完全週休2日制(土、日)・祝日・年末年始6日
■休暇：年次有休休暇・慶弔・赴任・リフレッシュ
受動喫煙対策：あり　就業場所　全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有