Senior Submissions Officer

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🕒 4 dias atrás

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

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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

• Support clients in all aspects of safety submissions • Support the Submission Manager with development, documentation, implementation, and maintenance of submission processes and standards • Maintain knowledge of global regulatory reporting requirements to ensure compliance • Perform submissions of ICSRs and aggregate reports to concerned parties • Perform ICSR exchanges with concerned parties according to applicable documents • Provide support for pharmacovigilance operations associated with safety reporting • Perform quality control of ICSR reportability assessments • Perform quality control of daily safety submission activities • Participate in training and maintain and develop quality system documents for the Safety Reporting area • Train junior team members • Act as a submissions subject matter expert during audits and inspections, representing submissions business processes and standards

🎯 Requisitos

• Life science graduate, pharmacy, nursing, or other healthcare-related qualification • 3–5 years of work experience in pharmacovigilance • At least 2 years of experience working on submissions • Organizational skills, including attention to detail and multitasking • Management skills, including time and issue management • Communication skills, including clear and effective interaction with internal and external stakeholders • Fluent English, spoken and written

🏖️ Benefícios

• Remote work option • Flexible work environment • Growth opportunities • Collaborative and supportive team culture • Training opportunities • Belonging-focused workplace • Opportunity to contribute to patient safety and global pharmaceutical treatments