Location: Japan - Tokyo
Salary: 8000000 - 12000000 JPY
Job Function: Drug Safety/PMS
Reference: JO-180315-149517
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals

Company

◆グローバルランキング15位以内

◆福利厚生充実且つ、離職率も業界水準よりも低め

◆豊富なパイプラインとコンパウンドを持っており、今後もスペシャリティケア領域を中心に増

◆フレキシビリティの高い働き方を推奨し、定年後も再雇用実績あり


Job Description

As part of the Japan Safety organization at Amgen Astellas BioPharma (AABP), the Japan Safety PV Mgr is responsible for:

  • Representing the local safety function in interactions with Regulatory agencies 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.
  • Participating in exchange of safety information with stakeholders to support informed understanding of product safety issues.
  • This position reports to Japan Safety PV Sr Mgr.

Facilitate patient access to the 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).
  • 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.

Key Activities ​

General

  • Execute safety (PV) processes for the 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
  • Participate in global/regional/country safety meetings to share best practice