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Japan Safety PV Manager

PV role in great firm

職種ファーマコビジランス
給与 1000 - 1500 万円
日付2018-05-23
業種製薬
勤務地東京
求人番号Job-00046306

会社概要:

It is the world’s largest independent biotechnology company. This company believes innovation in business, collaboration, resource-sharing and patient access is as critical to serving people’s health as what occurs in a laboratory.

業務内容:

Group Purpose ​ Facilitate patient access to company products in Japan through the following:

  • Compliance with applicable local regulations;
  • Development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant company processes;
  • Development and execution of Japan risk management plan (J-RMP);
  • Assessment of safety data in Japan; provision of safety expertise;
  • Leading and collaborating on post marketing surveillance (PMS) activities
  • Interface with regulatory agencies and industry organization;
  • Alignment with key cross-functional partners and business partners;
  • Continuous improvement of business processes.
Job Summary As part of the Japan Safety organization, the Japan Safety PV Mgr is responsible for:
  • Representing the local safety function in interactions with Regulatory agencies, other functions within AABP, staff members in Global Patient Safety, business partners, and external health care 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, company policies and procedures; and
  • Participating in exchange of safety information with stakeholders (company, 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 ​General
  • Execute safety (PV) processes for company 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 MOUs using Globally consistent formats
  • Train group and company employees on safety reporting needs in Japan
  • Participate in global/regional/country safety meetings to share best practice

応募条件:

RequirementsKnowledge 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)
  • Native level Japanese
 Education & Experience (Preferred)
  • Working knowledge of GVP, GCP (as applicable to Safety), GPSP, and other applicable regulations and guidelines in Japan
  • 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


BRS Consultant

Thomas Partridge

Pharma

Tel: 03-6370-7942

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