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
