Pharmacovigilance Associate

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🕒 Outubro 26

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

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• Aberta há 17 dias.
• Sem salário divulgado.

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Harrow

SiteLinkedInTodas as Vagas

201 - 500 funcionários

💊 Farmacêutico

🏥 Saúde

🏭 Manufatura

💰 $100.000.000 Post-IPO Debt em 2023-03

Pharmaceuticals • Healthcare • Manufacturing

A Harrow (NASDAQ: HROW) é uma líder em ascensão no mercado de saúde oftalmológica.

Descrição

• Assess adverse event reports for validity and seriousness, and triage and prioritize them by regulatory reporting timelines • Process new and follow-up Individual Case Safety Reports (ICSRs), including MedDRA coding and narrative writing • Engage healthcare professionals and stakeholders to gather additional adverse-event information • Support expedited 15-day Alert and non-expedited ICSR submissions to the FDA through E2B(R3) electronic submission • Exchange safety information with licensing and distribution partners and support monthly partner ICSR reconciliations • Screen literature search results for reportable cases and safety information • Support aggregate safety report preparation, including PADERs and DSURs, data pulls, line listings, and reconciliation • Perform quality checks and maintain inspection-ready documentation according to SOPs and work instructions • Communicate with regulatory authorities, healthcare professionals, and stakeholders on safety-related matters • Support pharmacovigilance operations as needed • Collaborate with clinical research, regulatory affairs, Quality, and medical affairs teams • Work under the general guidance of the Senior Pharmacovigilance Specialist

🎯 Requisitos

• Bachelor's degree in Life Sciences or a related field, or equivalent educational background • 2–3 years of experience in pharmacovigilance/drug safety, or a related area • Excellent written and verbal skills in English • Excellent analytical and problem-solving approach • Ability to work independently as well as within teams • Strong organizational and project management skills • Confidence, professionalism and credibility when interacting with customers and third parties • Understanding of compliance and quality management systems • Ability to travel independently as a Harrow Eye, LLC representative

🏖️ Benefícios

• Full-time employment • Remote work arrangement • Occasional travel up to 10% • Regular Monday–Friday operations, 9 am–5 pm • Weekend hours may be needed depending upon workload demands

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