Global Pharmacovigilance Scientist, Senior Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $140.8k - $190.5k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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