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              新着外資製薬メーカー

              セイフティーフィジシャン(MD)/ペイシェントセイフティー&ファーマコビジランス部

              • 新着求人
              • 英語を活かす

              大手外資系企業にてセイフティーフィジシャンを担当いただきます。

              仕事内容
              Accountabilities
              As an expert of benefit/risk (B/R) profile, which are assessed by global BR team and aligned among global and local, engage to take safety assurance measures such as preparation of J-RMP, proper use of drugs and closely work with evidence/asset team by providing B/R knowledge and work with global team by inputting local needs/insight.
              ・Lead to prepare local Risk management Plans in response to Japanese specific requirements (e.g. country-specific format) and content in liaison with GPV functions.
              ・Implementation and progress of global risk minimization measures, lead to prepare local RMP development and implementation not only for the delegated asset (AT) but also other products as needed. Provide PV input and insights to local labelling documents and educational materials (e.g. SPC, PIL) in time and quality.
              ・Perform local safety data monitoring not only for the delegated asset (AT) but also other products as needed. Timely information of the respective PVWG Chairperson on any relevant new safety information received from local sources for group products or for products of the same class.
              ・Promote implementation of safety assurance measure such as proper use of drug, including preparation of guidelines for them in collaboration with stakeholders (e.g.LRA, legal &complaince)
              ・Perform Medical Quality Review of all fatal / life-threatening cases as needed and defines appropriate follow-up measures. Complete ‘fatal case investigation’ report as needed.

              Manage health authority requests, potential safety issues and / or crisis management not only for the delegated asset (AT) but also other products as needed and together with global/local stakeholders.
              Contribute to the PSPV Culture, Local PSPV Strategy & the establishment and maintenance of a high-quality local PSPV system, Review controlled documents (e.g. PV Working Instruction, PV Repository, applicable sections in PSMF annexes, local SOPs, etc.) also contribute to Japan initiatives to promote Patient Safety & Pharmacovigilance concepts and conduct PV trainings, where the training needs were identified, for internal and external customers.

              To be ready for inspection and support to management of non-compliance
              ・Reporting of non-compliances as soon as becomes aware of the issue and Contribute to investigate non-compliances and associated CAPA (Corrective and Preventive Actions) activities. Take over CAPA Lead Function, if required.
              ・Establish and support local inspection readiness, participate in PV audits and PV/GPSP/GCP inspections.

              Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations
              Proactively cooperation with Global PSPV on any upcoming new regulations or group processes to assess the local impact and their implementation within the team.
              ・Contribute to seting up/optimizing of local PSPV processes including the takeover of subtasks e.g. creation/revision of the related documentation (Standard Operating Procedures (SOPs), Local PV System Framework, KMed Assets, etc.)

              Regulatory and / or Organisational Requirements
              Excellent knowledge of applicable global, regional and local PV regulations, group processes and relevant GxP requirements.
              Be compliant and acts within ethics at all times.

              Job Complexity
              The position requires extensive regulatory,scientific knowledge and balanced risk-based decision making. This needs to take into account needs and requirements of other functions, departments and units.

              Interfaces
              Local Medical Director, Global Patient Safety & Pharmacovigilance, MSG,CDMAs, LRA, MKT, SL, RWD
              GRA, CD&O

              Job Impact
              Conduct and Establish internal/external collaborations by sharing best practices
              応募条件
              【必須事項】
              ・Medical doctor
              ・Experience as clinician
              ・1+years’ experience at Experience at pharmaceutical industry at medicine department
              ・Experience in the field of clinical development is highly preferable
              ・Substantial knowledge about local GVP/GPSP regulation and global GVP regulation.
              ・Knowledge and experience of preparation of periodic report/RMP/EPPV
              ・Knowledge and experience of performing signal monitoring
              ・Knowledge and experience of PJ management
              ・Experience on industry activities (e.g. participating working group across companies) (preferable)
              ・Excellent command of English language (toeic score more than 785)

              Skill and Competencies
              ・Proactive and assertive attitude to establish team and networking
              ・Problem solving skill and crisis-management skills
              ・Analytical skills on industrial trend.
              ・Conceptual and strategic thinking
              ・Project management and decision-making skills
              ・Ability to mentor, coach and train others
              ・Proactive and assertive attitude with customer service orientation
              ・Excellent communication and presentation skills

              Language skills:
              • Japanese: Native
              • English: Fluent
              Required English speaking CEFR level : B2
              【歓迎経験】

              【免許・資格】

              【勤務開始日】
              応相談
              勤務地
              【住所】東京
              年収・給与
              900万円~1300万円 経験により応相談
              検討する
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