Global Pharmacovigilance Scientist, Manager – Oncology

🕒 Outubro 1

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $116.167 - $157.168 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 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

• Partner closely with Global Safety Officers, Clinical Development, Regulatory Affairs, and other cross-functional stakeholders to develop and execute product safety strategies across the product lifecycle • Lead signal detection, validation, prioritization, evaluation, and management using multiple safety data sources and methodologies • Conduct scientific and medical evaluation of adverse events and emerging safety concerns from clinical trials, post-marketing surveillance, literature, and external data sources • Perform complex safety analyses and communicate evidence-based recommendations supporting product safety decisions • Integrate safety databases, clinical studies, literature, epidemiology, and external sources to assess potential safety signals • Support benefit-risk evaluations informing product development, regulatory submissions, labeling updates, and lifecycle management • Lead or contribute to planning, preparation, authoring, review, and submission of aggregate safety reports, including PBRERs/PSURs, DSURs, Safety Assessment Reports, and regulatory safety responses • Provide strategic safety input into clinical protocols, statistical analysis plans, safety analysis plans, investigator brochures, and clinical study reports • Review and recommend improvements to safety data presentations, including tables, figures, and listings • Represent Global Patient Safety within safety governance and cross-functional teams • Present safety analyses, emerging signals, benefit-risk assessments, and Global Safety Team recommendations to governance committees and decision-making bodies • Contribute to global risk management strategies, Risk Management Plans, risk minimization activities, and regulatory documentation • Support regulatory submissions, health authority interactions, product launches, and lifecycle management initiatives • Support regulatory inspections, audits, pharmacovigilance compliance activities, and continuous inspection readiness • Undertake activities delegated by the Qualified Person for Pharmacovigilance as described within the Pharmacovigilance System Master File • Ensure compliance with global pharmacovigilance regulations, GVP guidance, ICH requirements, and internal Amgen procedures • Lead or support initiatives improving pharmacovigilance processes, methodologies, quality, compliance, and operational efficiency • Participate in implementation of new safety processes, technologies, and methodologies • Provide scientific leadership and mentorship to junior pharmacovigilance scientists and project team members • Contribute to safety strategy discussions supporting oncology, immunology, inflammation, rare disease, and biologic development programs • Perform other duties related to the position as assigned by management or described in applicable procedures

🎯 Requisitos

• Doctorate degree OR Master’s degree and 2 years of Industry Pharmacovigilance experience OR Bachelor’s degree and 4 years of Industry Pharmacovigilance experience OR Associate’s degree and 8 years of Industry Pharmacovigilance experience OR High school diploma / GED and 10 years of Industry Pharmacovigilance experience • Advanced scientific or healthcare degree preferred (PharmD, PhD, RN, NP, PA, MD, or equivalent scientific discipline) • 5+ years of pharmacovigilance or drug safety experience within biotechnology, pharmaceutical, or CRO environments • Demonstrated experience in signal detection, signal evaluation, signal analysis, and signal management activities • Experience authoring and/or reviewing aggregate safety reports including PBRERs, PSURs, DSURs, and Safety Assessment Reports • Experience supporting benefit-risk assessments for investigational and/or marketed products • Experience developing, maintaining, or supporting Risk Management Plans (RMPs), REMS, or other risk minimization strategies • Experience utilizing literature surveillance and external data sources to support signal detection and safety assessments • Experience using Argus Safety and/or other global safety databases and signal management tools • Knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations and guidance • Experience supporting regulatory submissions, inspections, audits, and health authority responses • Clinical development, medical affairs, clinical research, and/or pharmacovigilance experience supporting products in both development and post-marketing settings • Experience within oncology, immunology, inflammation, rare disease, biologics, or related therapeutic areas preferred • Demonstrated clinical and scientific judgment with the ability to interpret complex safety data and communicate risk effectively • Proven ability to influence and lead within a highly matrixed, cross-functional environment • Experience presenting safety assessments and recommendations to governance committees and senior leadership • Excellent written, verbal, presentation, and stakeholder management skills • Sponsorship for this role is not guaranteed

🏖️ 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Financial plans with opportunities to save towards retirement or other goals • Career development opportunities • Reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment

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