Local Safety Officer

ジョブ番号: 1324

外部説明:

• 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

ジョブ番号: 1324

コミュニティステータス: Local Safety Officer

Location_formattedLocationLong: Tokyo, Tokyo JP