Global Pharmacovigilance Scientist, Senior Manager

🕒 Setembro 11

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $140.799 - $190.492 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Work with Therapeutic Safety Teams on safety assessment activities for medical/scientific operations • Direct planning, preparation, writing and review of portions of aggregate reports • Organize and direct liaison activities with affiliates and internal Amgen partners regarding products • Support and provide oversight to staff regarding clinical-trial safety • Review and provide input on study protocols, statistical analysis plans and other clinical study documents • Review adverse events and serious adverse events from clinical trials as needed • Review standard safety-data tables, figures and listings • Participate in developing safety-related data collection forms and study team meetings • Perform signal detection, evaluation and management through safety-data analysis • Document work in the safety information management system • Author Safety Assessment Reports, safety documents and regulatory responses with the GSO • Search and review adverse-event data, literature and other safety-relevant data for signal detection • Present Global Safety Team recommendations to cross-functional decision-making bodies • Assist with risk-management strategies, plans, risk minimization activities and regulatory inquiries • Support safety-related activities for new drug applications and other regulatory filings • Undertake delegated QPPV activities and maintain inspection readiness • Serve as representative and point of contact for Health Authority Inspections and Internal Process Audits

🎯 Requisitos

• Doctorate degree and 2 years of industry pharmacovigilance experience, OR Master’s degree and 4 years of industry pharmacovigilance experience, OR Bachelor’s degree and 6 years of industry pharmacovigilance experience, OR Associate’s degree and 10 years of industry pharmacovigilance experience, OR high school diploma/GED and 12 years of industry pharmacovigilance experience • Experience in signal detection, evaluation and management • Experience of literature surveillance, including source document review knowledge and skills • Experience in aggregate data analysis, interpretation and synthesis • Good clinical and scientific judgment • Clinical and/or medical research experience • Understanding of qualitative and quantitative safety data analysis methods • Sponsorship for this role is not guaranteed

🏖️ Benefícios

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support

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