Local Safety Officer

2週間前

Location: Tokyo, Tokyo JP Randstad Sourceright

Job Number:

External Description:

  • Medical safety management of GPV local products:
  • Serve as a clinical and post-marketing medical safety expert in the country
  • Accountable for all signal management activities in the country & ensures that the local product labels and risk management plans are properly aligned with the benefit risk of the products.
  • Responsible of the safety surveillance of assigned GPV global and local products, in compliance with local regulations and group procedures. This includes (but not limited to):
  • Handling of local Regulatory Authorities safety queries,
  • Preparation and writing of periodic safety reports,
  • Management of safety signal (detection including literature screening, validation, analysis),
  • Preparation and writing of risk management plans,
  • Labelling updates,
  • Health hazard evaluations
  • Local studies documents
  • Work in close collaboration with Regions Medical Safety & Processes Coordination Head to ensure appropriate assessment of Safety information related to local products.
  • Serve as the back up to country RPP/Local QPPV (if applicable by national regulations) for the products of all applicable entities.
  • Can serve as the CSH back-up where applicable
  • Local, Region and Global Partnership
  • Local:
  • Serves as a back-up to local Responsible Person for Pharmacovigilance as needed
  • Can act as a back-up to Country Safety Head and/or Region Safety Head when applicable
  • Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests: participate actively to local meetings/committees such as MRPQ meeting (when applicable), deliver presentations and participate in working groups.
  • Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly:
  • Secure with Medical Information, Clinical Study Unit, Quality, Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner
  • Contribute to the development of local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions.
  • Region/Global:
  • Identify issues or dysfunction in the assigned country(ies) and escalate to Country Safety Head/CSH and/or directly to the RSH/QPPV.
  • In case of PV outsourcing activities, collaborate with Regions Resources & Budget Lead in -Global PV management office to implement the best outsourced capabilities.
  • Interact with the Global Safety Officer (GSO) for relevant questions related to the safety profile of product originating from HA or any other sources.
  • Management responsibilities:
  • Manage PV staff member(s) directly or cross-functionally:
  • Provide leadership, mentorship and supervision to his/her team (e.g. leading regular team meetings) to ensure transparency and alignment on strategic direction, goals, processes and objectives
  • Sets up the appropriate resources and qualification of the team, evaluates team performance and fosters training and personal development by effective talent management and recognition

    • Job Number:

    Community / Marketing Title:
    Local Safety Officer

    Location_formattedLocationLong:
    Tokyo, Tokyo JP

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