お仕事情報

お仕事情報

Japan Safety Pharmacovigilance (PV) Mgr:SS-4154MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-4154MY
募集職種 Japan Safety Pharmacovigilance (PV) Mgr
職務内容 Job Summary:
As part of the Japan Safety organization at us, the Japan Safety PV Mgr
is responsible for: representing the local safety function in interactions with Regulatory agencies, other functions within us, staff members in Global Patient Safety, business partners, and external healthcare professionals, to achieve Safety objectives; helping ensure compliant and efficient performance of local safety activities based on sound knowledge of local legislative requirements and practice, us
policies and procedures; and participating in exchange of safety information with stakeholders us, partners, and external; local, regional, and global) to support informed understanding of product safety issues.
This position reports to Japan Safety PV Sr Mgr

Key Activities:
Perform the following tasks, under the direction and guidance of the Head of Japan Safety, Japan Safety PV Sr Mgr

<General>
・Execute safety (PV) processes for Amgen products
・Represent the Safety function on local product team(s) and joint product team(s)
・Ensure safety compliance review and quality of safety part of CTN and NDA dossiers in
Japan
・Contribute to and facilitate the creation and improvement of local business processes and system infrastructure for safety information collection and management

<Safety Reporting and Safety Database>
・Facilitate Safety Database conventions development and maintain current awareness of those conventions
・Perform assigned tasks in the ICSR handling workflow and the preparation and submission of Japan-specific periodic safety reports
・Facilitate development of productivity and compliance metrics for AE processing

<Risk Management and Risk Communication>
・Collaborate with cross-functional stakeholders on risk management planning and local risk minimization actions Compliance and Regulatory
・Advocate safety compliance
・Prepare for and participate in regulatory inspections by Regulatory Authorities
・Negotiate with local regulatory agency officials on safety related topics
・Training and Other Cross-functional Activities
・Lead and educate safety associate for safety activities
・Develop Safety data exchange agreements and memorandum of understanding (MOU)
using Globally consistent formats
・Train employees on safety reporting needs in Japan
・Participate in global/regional/country safety meetings to share best practice
応募要件 Knowledge and Skills:
・Experience in directly related to safety areas including PV regulations
・Defining, authoring, and implementing policies, procedures and SOPs
・Project management skills
・Communication skills and ability to collaborate in cross-functional team settings
・English language proficiency (business discussions, reading, and writing

Education & Experience (Basic):
・Not applicable for positions in Japan

Education & Experience (Preferred)
・Work experience in the planning and execution of pharmacovigilance and safety surveillance activities during clinical development and in the post-marketing setting
・Current nursing or paramedical professional license or Pharmacist
勤務地 東京
年収 1000万円~1300万円
最終学歴 理系大卒
推奨される資格要件 PhD、理系
その他

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