Global Safety Senior Manager, Hematology Oncology - Remote

Overview

The Global Safety Senior Manager for Hematology Oncology at Amgen will play a vital role in supporting safety assessment activities and providing scientific and compliance expertise to the Global Patient Safety organization.

In Short

• Support safety assessment activities for medical and scientific operations.
• Review adverse event data and perform data analysis for safety signals.
• Author safety assessment reports and regulatory responses.
• Support clinical trial-related activities and provide oversight on safety.
• Assist in the development of risk management strategies and activities.
• Support new drug applications and safety-related regulatory activities.
• Document work in the safety information management system.
• Act as a liaison for safety activities with affiliates.
• Represent Amgen during health authority inspections and internal audits.
• Collaborate with cross-functional teams on safety issues.

Requirements

• Doctorate degree with 2 years of related experience or equivalent qualifications.
• Experience in a biotech/pharmaceutical setting.
• Management or mentoring experience preferred.
• Expertise in signal detection and data analysis.
• Experience with periodic aggregate safety reports.
• Knowledge of ICH guidelines and safety systems.
• Clinical and/or medical research experience.
• Strong communication and collaboration skills.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plan with company contributions.
• Medical, dental, and vision coverage.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid options.