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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.- Forward any health authority request to applicable PSRM stakeholders.- Support drafting, negotiating, and executing Pharmacovigilance Agreements (PVAs) for products marketed in the territory under their responsibility in accordance with the applicable global Standard Operating Procedure (SOP) and associated templates. Inform PSRM Contracts (of any new PVA under negotiation or revision.- Completion of the Affiliate Monthly PV Reporting Form in accordance which includes the regular checks of information about local PV Service Provider (as applicable) in the respective inventory.- Notifying and documenting registration as National Qualified Person / PV Responsible Person to the national health authority.- Other duties as assigned by Manager/ Regional Management.BASIC QUALIFICATIONS- Healthcare professional (nurse, pharmacist, etc.) with pharmacovigilance training and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.- Colleague must be able to be nominated as Pharmacovigilance Responsible to the local health authority.- Knowledge of local pharmacovigilance legislation (NOM-220), and industry best practices.- Fluent in Spanish and English.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer.LI-Remote
