.Select how often (in days) to receive an alert:Deputy Local Safety Officer (Italiano)Date: 25 Sep 2024Location: Madrid, Spain, 28223Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.Deputy Local Safety OfficerThe Position: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
