Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

🕒 Setembro 22

🌐 Estados Unidos, Sérvia, +2 outros países – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇷🇸 Sérvia – Remoto 🇭🇷 Croácia – Remoto 🇲🇰 Macedônia do Norte – Remoto

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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ProPharma

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 2001

🏥 Saúde

📦 Logística

🏭 Manufatura

💰 $8.600.000 Venture Round em 2020-10

Healthcare • Logistics • Manufacturing

A ProPharma é uma organização líder em consultoria de pesquisa na indústria de ciências biológicas. A empresa é especializada em fornecer soluções personalizadas ao longo de todo o ciclo de vida do produto, desde a descoberta inicial até o monitoramento pós-mercado. Os serviços da ProPharma incluem ciências regulatórias, soluções em pesquisa clínica, serviços de qualidade e conformidade, farmacovigilância, informação médica e tecnologia de P&D. Conhecida por sua profunda expertise no domínio, a ProPharma auxilia clientes nos setores farmacêutico, biotecnológico e de dispositivos médicos com suporte regulatório, desenvolvimento clínico e gerenciamento da qualidade. A equipe global da ProPharma apoia uma ampla gama de áreas terapêuticas, incluindo oncologia, cardiovascular e doenças raras, entre outras, garantindo a entrega eficaz e eficiente de terapias que salvam vidas.

Descrição

• Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges • Ensure compliance with global pharmacovigilance reporting requirements and internal procedures • Conduct monthly ICSR reconciliation activities with clients and safety partners • Support gateway-to-gateway testing for health authority submissions and safety partner exchanges • Assist with investigation, documentation, and resolution of submission-related deviations and CAPAs • Generate Argus-based line listings and summary tabulations for periodic safety reports • Assist in creating, validating, and quality reviewing custom reports and reporting outputs • Support setup, verification, and maintenance of periodic reporting requirements across global markets • Coordinate periodic report submissions in compliance with local regulatory requirements • Support pharmacovigilance reporting services and operational excellence • Research, collect, and maintain global pharmacovigilance reporting requirements • Conduct monthly regulatory surveillance and impact assessments • Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects • Provide guidance on evolving pharmacovigilance regulations and reporting obligations • Perform Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments • Support implementation and validation of territory-specific and custom E2B profiles • Participate in data migration testing and submissions-related system enhancements • Contribute to projects improving efficiency, quality, and system performance • Prepare and maintain xEVMPD submissions, updates, removals, and new product entries • Conduct peer review and quality control of xEVMPD submissions • Support bulk updates, QPPV changes, master file location updates, and developmental product registrations

🎯 Requisitos

• High school diploma required • Post-secondary education in a life sciences discipline is preferred • Equivalent professional experience in pharmacovigilance regulatory submissions or regulatory intelligence will also be considered • Minimum of 3 years' experience working with pharmacovigilance safety databases • Experience with safety reporting, ICSR submissions, E2B exchanges, and regulatory compliance activities preferred • Experience with Oracle Argus Safety or similar safety databases highly desirable • Knowledge of xEVMPD and global pharmacovigilance regulations is an advantage • Strong attention to detail and commitment to quality • Excellent verbal and written communication skills • Strong organizational and problem-solving abilities • Ability to manage multiple priorities and adapt to changing business needs • Ability to work independently while collaborating effectively within cross-functional and global teams • Proficiency in Microsoft Office applications, including Outlook, Word, and Excel

🏖️ Benefícios

• Work with a global team of pharmacovigilance and regulatory experts • Gain exposure to international safety reporting requirements and health authority interactions • Contribute to meaningful projects supporting patient safety and regulatory compliance worldwide • Develop expertise across submissions, regulatory intelligence, testing, and PV systems • Hybrid working encouraged for new hires based within a reasonably short commute of an office, as agreed with the manager • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion