Senior Global Safety Manager, Rare Disease

Job not on LinkedIn

October 28

Apply Now

Receive Emails with Similar Jobs

Amgen

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Science

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.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations • Provide scientific and compliance expertise to Global Patient Safety (GPS) • Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection • Perform data analysis to evaluate safety signals and write up analysis results • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO) • Direct the planning, preparation, writing and review of safety portions of aggregate reports • 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 • Support activities related to new drug applications and other regulatory filings • Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products • Provide support for clinical trials to review and provide input to study-related documents

🎯 Requirements

• Doctorate degree and 2 years of proven experience OR Master’s degree and 4 years of proven experience OR Bachelor’s degree and 6 years of proven experience OR Associate’s degree and 10 years of proven experience OR High school diploma / GED and 12 years of proven experience • RN, PharmD, MPH or PA Preferred • Extensive direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production • Knowledge of processes and regulations for pharmacovigilance and risk management • Clinical/medical research experience

🏖️ Benefits

• A 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 • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements