Global Pharmacovigilance Scientist, Manager – Oncology

🕒 il y a 1 jour

🇺🇸 États-Unis – Télétravail

💵 $116 167 - $157 168 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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