Deputy Local Safety Officer

hace 3 semanas

Albacete, España Daiichi Sankyo Europe A tiempo completo

.This position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks.Act as the Deputy of the National PV Contact Persons in Spain and Italy.This position will act as a back-up for the LSOs to support their implementation of the DSE PV policy strategy, assuring the local PV system is operating appropriately by overseeing and executing operational PV tasks in Spain and Italy.The individual will be accountable for liaising with other DSES and DSIT stakeholders (e.G. Regulatory, Medical Affairs, Marketing) as well as local PV vendors, and providing PV Training to the relevant local functions and external parties as necessary to ensure PV processes are implemented properly.This position will report to the Local Safety Officer in Spain and is expected to work independently with minimal guidance with specialized knowledge, and use expertise to analyze and solve problems.Roles and ResponsibilitiesAct as back-up of the primary contact point/nominated person for pharmacovigilance for the Spanish and Italian Health Authorities.Responsible for supporting the LSOs in performing/overseeing all local PV activities in Spain and Italy.Supports the LSOs in ensuring safety report collection process is implemented and oversees the processes are working properly.Involved in creating and updating local procedures in line with regulatory requirements and European PV processes.Responsible for acting as contact person for pharmacists, physicians, and consumers for the reporting of adverse events (AEs) and Product Technical Complaints (PTCs) to collect safety information and their follow-up activities.Performs/oversees local literature screening, monitoring of local PV legislation, and implementation of Risk Management Plans (RMPs) and additional Risk Minimization Measures at a local level as required.Liaises with local stakeholders (e.G. Medical, Marketing) as well as local PV vendors, and providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly (e.G. Market Research Programs).Contributes to the maintenance of the EU Pharmacovigilance System Master File (PSMF) by providing up-to-date information from the local PV system.Contributes to the company's benefit-risk evaluation for Daiichi Sankyo products and to answering requests from Competent Authorities.Acts as a key contributor for the GVP affiliate audits/inspections in Spain and Italy.PV process enhancement:Contributes to the enhancement of EU affiliates PV Quality Management System standards by providing the inputs from local PV Systems.Facilitates the local implementation of global processes (e.G

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    Albacete, Albacete, España Datamars A tiempo completo

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    Albacete, España Kbr A tiempo completo

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    Albacete, España Kbr A tiempo completo

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    Albacete, Albacete, España Datamars A tiempo completo

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    Albacete, España Kbr A tiempo completo

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    hace 5 meses

    Albacete, España Airbus A tiempo completo

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