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Safety Manager

2 months ago

Bangalore City, India Excelya Full time
ExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.To learn more about us, visit Safety manager is responsible for managing the Team and ensure all processLine Management of Case processing team Safety officerEnsure all processes are deployed and applied by the Safety team for Individual Case Safety Report management activities Snr Safety project Manager support on Back Office management activitesSafety Team Leader support on Back Office management activitesSafety Officer support on Back Office Management activites Education and ExperienceAt least 6 years of previous working experience in PharmacovigilanceAt least 3 years of managerial experience in healthcare sector preferably with line management activityStrong understanding of global pharmacovigilance regulations, such as FDA, EMA, MHRA, ICH, and GVP guidelinesProficiency in core pharmacovigilance activities (case management, reconciliation, literature monitoring, etc.)Strategic thinking and problem-solving personalityExcellent communication and presentation skillsEfficiency in allocating resources, managing workloads and identifying opportunities for process optimizationAbility to lead, motivate and inspire a teamSelf-confidence;

self-motivated with high emotional intelligenceMulti-tasking with excellent organizational skillsExperience in regulatory inspections and internal/external auditsFluency in English