Pharmacovigilance Specialist

Detalles de la oferta

.Viatris Healthcare México S. de R.L. de C.VAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access - Providing high quality trusted medicines regardless of geography or circumstance; Leadership - Advancing sustainable operations and innovative solutions to improve patient health; andPartnership - Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference and here's how the Pharmacovigilance Specialist role will make an impact:The Pharmacovigilance Specialist acts as Affiliate Safety Representative (ASR) and nominated Pharmacovigilance Responsible for Viatris Mexico, responsible for the local Mexico affiliate pharmacovigilance system in accordance with company procedures, and applicable global and local pharmacovigilance regulation.The Pharmacovigilance Specialist is responsible to organize, implement, and maintain the Mexico Affiliate PV System which includes, but is not limited to:- Implementation of PSRM standards and procedures, as applicable.- Track and communicate changes in local PV regulations that may have an impact on standards and procedures of Global PSRM.- Development and implementation of local procedures, as necessary.- Pharmacovigilance training for local country personnel/agents and for 3rd parties as applicable.- Local implementation and tracking of activities in accordance with Risk Management Plans (RMPs) and implementation of a local procedure covering the local implementation of Risk Management Plans.- Collection of PV-relevant information and reporting of Individual Case Safety Reports (ICSRs).- Reconciliation of exchange of relevant documents (such as source data of ICSRs), as applicable, with Global PSRM, affiliate non-PV functions, commercial partners, service providers, etc.- Local medical literature screening as required by local legislation or guidance.- Timely identification and appropriate response to incidents of noncompliance.- Inform Safety Surveillance Team (SST) about the requirement/change in requirement for any Periodic Safety Update Report (PSUR) in liaison with local Regulatory Affairs.- Provide safety information required for preparation of periodic safety report, upon request to SST.- Inform SST about any potential signal or safety concern identified at local level.- Inform applicable PSRM stakeholders concerning urgent safety restrictions.- Archiving of local PV documents as per PSRM standards and procedures, and local regulations.- Business continuity management for critical PV processes.- Ensuring continual readiness for audits and inspections.- Notify applicable PSRM stakeholders of any local PV audit by a 3rd party, self-inspection, or any health authority inspection upon announcement


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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