Senior Manager, Global Pharmacovigilance Safety – Obesity

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🕒 Julho 6

🇺🇸 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

• Directs the planning, preparation, writing and review of portions of aggregate reports • Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products • Supports and provides oversight to staff with regards to safety in clinical trials • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents • Review of AEs/SAEs from clinical trials as needed • Review standard design of tables, figures, and listings for safety data from clinical studies • Participate in development of safety-related data collection forms for clinical studies • Participate in study team meetings as requested or needed • Signal detection, evaluation, and management • Perform data analysis to evaluate safety signals and write up analysis results • Documents work as required in the safety information management system • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body • Assist GSO in the development of risk management strategy and activities • Provides contents for risk management plans • Develop or update strategy and content for regional risk management plans • Assist GSOs to oversee risk minimization activities including tracking of activities as needed • Evaluate risk minimization activity • Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO • Support activities related to new drug applications and other regulatory filings • Assist GSO in developing a strategy for safety-related regulatory activities • Provide safety contents for filings • Inspection Readiness • Undertake activities delegated by the QPPV as detailed in the PV System Master File • Maintain a state of inspection readiness.

🎯 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 • Bachelor’s in life science • 2 years of managerial experience directly managing people or projects and/or mentoring experience • Clinical or medical research experience • 6 years of experience in the biotech/pharmaceutical setting

🏖️ Benefícios

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.