Head of Safety Management, Japan

で見つかりました。 Talent JP C2 - 2日前

Chiyoda Jazz Pharmaceuticals Full time

JOB PURPOSE

The Safety Management Responsible Person (安全管理責任者), as stipulated in Good Pharmacovigilance Practice (GVP) in Japan, shall manage and direct the safety affairs of the company, GW Pharma ., in order to maintain marketing authorization and adhere to regulatory requirements related to safety management for GW Pharma and its products in Japan.

The Safety Management Responsible Person (安全管理責任者) shall represent GW Pharma . in terms of safety management supporting the Supervisor General, Sokatsu,(総括製造販売責任者).

KEY RESPONSIBILITIES/ACCOUNTABILITIES

  • Function as Anseki (安全管理責任者) stipulated in the GVP to support the Sanyaku (three officers in MAH) organization within the Japan office
  • Lead the preparation and execution of Safety Management activities for Japan
  • Acts as key contact person for GVP in Japan

    • DETAILED RESPONSIBILITIES/ACCOUNTABILITIES

  • Accountable for overall local pharmacovigilance activities in Japan as the GVP Safety Management Responsible Person (Anseki (安全管理責任者)
  • Develop necessary SOPs required to apply for an MAH license and in support of JNDA submission(s)
  • Responsible for developing and establishing a local Pharmacovigilance (PV) system in Japan, as well as oversight and management of the same.
  • Responsible for developing processes and operating procedures to ensure compliance with appropriate local pharmacovigilance regulations and quality standards in Japan for both approved products and clinical trials in Japan and relevant company SOPs.
  • Manage and ensure oversight of Safety Management processes including, but not limited to, information gathering, case evaluation, safety measurement planning and execution, training, record management, safety report submission and periodic report submission.
  • Responsible for developing processes and operating procedures to ensure compliance of Risk Management Plans (RMPs) and Post Marketing Surveillance (PMS/EPPV) responsibilities in Japan.
  • Responsible for developing a Japan Risk Management Plan (J-RMP) and leading the execution of PV activities including Post Marketing Surveillance (PMS) (or Phase 4 studies) of Jazz/GW products throughout the entire product's life cycle.
  • Responsible for input and contribution in the delivery of regional risk management plans to include risk minimisation activities as well as records of implementation, working closely with Jazz/GW colleagues and EU/International partners and guarantee their oversight.
  • Participate in the creation of protocols including purpose, method, implementation timeframe and other associated activities related to early post-marketing surveillance (EPPV) in collaboration with appropriate departments, ensuring implementation of new/revised processes to facilitate/improve EPPV and post-marketing safety management
  • Author/lead responses to regulatory queries for post-marketing safety matters in collaboration with relevant functions including Global PV Operations.
  • Coordinate required data output from the safety database to support communication with external stakeholders in Japan.
  • Escalate any actual or potential compliance issue to relevant operational bodies in Japan and as well as to appropriate global teams in Jazz/GW.
  • Maintain awareness of changes to regulatory guidance documents, requirements and PV processes.
  • Own compliance assessment and remediation plans while influencing execution, communication and training for Safety Management matters
  • Provide support for routine activities, projects, development and training relevant to area of expertise where required, ensuring accurate and up-to-date training records.
  • Supervise safety assurance activities in order to confirm that safety assurance operations are performed correctly and competently and create and store records thereof.
  • Work closely with the quality assurance manager regarding discard, recall, suspended sales, amended information such as package inserts or precautions, and provide information from by those responsible for managing information on pharmaceuticals, medical devices, and regenerative medicine products to medical staff or the Minister of Health, Labor and Welfare if legally obliged, and draft countermeasures to ensure safety, if deemed necessary
  • Create and maintain procedures for examination of safety control information, drafting countermeasures based on the results thereof.
  • In collaboration with appropriate departments, ensure PV obligations are adequately and clearly specified in relevant contractual agreements with business partners and/or external service providers.
  • Maintain inspection readiness for PV and GCP audits and inspections and engage in regulatory inspections and internal audits; preparing audit observation responses as necessary.
  • Act as a pharmacovigilance primary point of contact for the PDMA and PV audits and inspections
  • Participate in other assigned global PV activities as required
  • Participate in periodic oversight meetings held by EU/International PV and QPPV Office team; escalate safety-related issues to Head of EU/International PV & EEA QPPV.

    • KEY ATTRIBUTES/SKILLS/EDUCATION – ESSENTIAL
    Attributes

  • Minimum 10 years of related pharmaceutical industry regulatory experience
  • At least 5 years of PV/Drug Safety experience in a pharmaceutical industry (at least 3 years in a supervisory or managerial role) including creation and maintenance of a GVP system in Japan (ideally at a Japan start up subsidiary of a foreign pharmaceutical company).
  • In-depth knowledge of ICH and Japanese regulatory requirements, especially in PV.
  • Proficient with Safety Reporting systems
  • Ability to identify root cause of problem and creatively problem solve to gain resolution
  • Ability to prioritize and handle multiple projects simultaneously.
  • Ability to create Japanese GVP related documents
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
  • Native level in Japanese and sufficient English level (speaking & writing English) to achieve communication/discussion with global team is required
  • Excellent oral and written communication skills, liaising with multiple stakeholders both internally and externally including Japanese Health Authorities.
  • Excellent leadership skills and ability to work in a team
  • Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint)

    • KEY ATTRIBUTES/SKILLS/EDUCATION – DESIRABLE
    Attributes

  • Education required: BS Degree in scientific disciplines, MS/PhD preferred
  • Medical Doctor license, Pharmacist license (preferable)
  • Experience of leading PMDA or local government audit/inspection (preferable)
  • Experience of leading Japan Health Authority interactions related to Safety Issues. (preferable)
  • Experience being in Sokatsu role (preferable)

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