Senior Pharmacovigilance Officer – Team Lead, Case Processing Manager – Medical Device Experience

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🕒 Agosto 6

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ERGOMED

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1997

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

ERGOMED é um grupo global que oferece serviços especializados para as indústrias de biotecnologia e farmacêutica. Opera sob diferentes linhas de serviço, incluindo Ergomed Clinical Research, PrimeVigilance, e ADAMAS Consulting, e é dedicada a fornecer capacidades completas de organização de pesquisa clínica (CRO). Com foco em oncologia, doenças raras e estudos complexos, também oferece serviços completos de farmacovigilância e informações médicas, bem como auditorias abrangentes de GxP. A Ergomed está comprometida em apoiar o desenvolvimento de medicamentos com presença global em cerca de 100 países.

Descrição

• Lead the team responsible for ICSR management for selected projects or groups of projects • Line manage ICSR staff • Distribute tasks and oversee workflow processes for assigned projects and teams • Ensure effective cooperation with clients in ICSR Management • Support achievement of company goals and objectives • Provide support to project team activities on behalf of clients and the company • Create and maintain project-specific KPIs for contracted ICSR activities • Optimize procedures, trainings, and actions to increase ICSR team efficiency • Propose process changes to the ICSR Operational Lead • Manage ICSR deviations with support from the ICSR Operational Lead • Review trackers and timesheet data and ensure accuracy • Participate in ICSR processing and second quality control of cases • Support other departments as instructed • Operate as the assigned team subject-matter expert • Support the RA & PV Network Department, including acting as LCPPV for the specified country and PRLS for the designated language

🎯 Requisitos

• Life science graduate, pharmacy, nursing, another healthcare-related qualification, or experience in pharmacovigilance • Strong previous work experience in pharmacovigilance • Minimum 1 year of work experience in a line manager role • Medical Device experience required • Excellent written and verbal communication skills • Organization skills, attention to detail, and multitasking ability • Delegation skills • Planning and time management skills • Technical skills • Team-working skills • Fluent English, spoken and written • Advanced literacy in MS Office

🏖️ Benefícios

• Remote work • Collaborative team environment • Flexible culture • Growth opportunities • Diverse and inclusive workplace • Opportunity to work with global teams • Professional purpose and global reach