Swedish Orphan Biovitrum Japan株式会社
The PV Risk manager will:
- Contributes to setting the strategic direction within pharmacovigilance in collaboration with the global Safety Physician, demonstrates leadership behaviours within the Japan R&D/Medical Hub and, from a safety perspective, on the project/products being worked on. This includes execution of safety surveillance activities for the products where Sobi Japan is MAH, for products in development and wherever any safety data exchange agreements exist with 3rd parties, e.g. local signal detection, evaluation and contribution to the development of safety standards and processes, and safety strategy in clinical development.
- Collaborate with GPV/GMA/Japan R&D/Medical and other stakeholders to ensure that local PV activities are conducted to the highest ethical and scientific standards in compliance with global policies, local GCP, GVP, J-PAL and related local regulatory requirements.
The PV Risk manager is directly responsible for MAH products in Japan and/or products in development including:
• Secures the integrity and high standards in the handling of adverse events and risk management activities at local level, including for:
Local follow-up on adverse events/safety reports as requested by GPV
Preparation for CTD safety module for J-MAA submission
Preparation a high quality of J-RMP, J-PSUR(safety part), J-DSUR, re-examination dossier(safety part) and other related local regulatory periodic reports(e.g. non serious/unexpected periodic report, periodic infection report, periodic device deficiency report)
Create J-RMP and related materials(e.g. Proper use guide for HCPs/Patient Guide,etc.)
Establish aRMM system collaborate with GPSP manager and/or other related person (e.g. controlled distribution, EPPV, etc.)
Implementation and tracking of local risk minimization activities (including EPPV)
• Contribute as local PV representative in clinical study teams including responsibilities such as preparation of Safety Management Plan, review of safety data, participating in scientific discussions related to safety, development of documents, and preparation for submissions for e.g. new indications/drug approval
• Develop and maintain safety related systems, processes, and procedural documents at local level (e.g. J-GVP SOPs, J-RMP, local literature search,etc.)
• Provide high quality and timely contributions to responses to safety-related enquiries for Sobi Japan MAH products i.e. from local regulatory authorities and other stakeholders.
• Responsible for management of any vendors performing PV activities locally.
• Contribute to develop PV related agreements (e.g., contracts with HP, ESP, PSP providers, Market Research providers) include PV clauses.
• Contribute to the whole process of sobi safety database system preparation activities to fulfil the local regulatory requirements
• Keeps up to date with local regulatory requirements for PV activities, supporting interpretation and implementation of new or existing legal requirements.
• Performed properly and smoothly of local inspections (e.g., GPSP conformance inspection, inspection for renewal business license) and global PV audits and management of Non-Conformance (NC) and CAPAs.
• Adequate trainings in the safety reporting requirements to any persons working for Sobi locally including 3rd parties, external service providers in accordance to J-GVP.
• Implementation of self-inspection in accordance to J-GVP
スウェーデンのストックホルムに拠点を置く、血液学、免疫学、および専門医療の分野での治療を専門とする国際的なバイオ医薬品企業です。