Senior Manager, Global Pharmacovigilance Safety – Obesity

🔥 2 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 oversee staff regarding clinical-trial safety activities • Review study protocols, statistical analysis plans and clinical study-related documents • Review adverse events and serious adverse events from clinical trials • Review 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 • 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 • Maintain inspection readiness and serve as a 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 • 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 • Sponsorship for this role is not guaranteed

🏖️ Benefits

• Comprehensive employee benefits package • 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