Global Pharmacovigilance Scientist, Senior Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Therapeutic Safety Teams on safety assessment initiatives related to medical and scientific operations

• Oversee the planning, preparation, writing, and review of sections of aggregate reports

• Coordinate and manage liaison activities with affiliates and internal partners at Amgen concerning products

• Provide support and guidance to staff on matters related to clinical-trial safety

• Evaluate and contribute to study protocols, statistical analysis plans, and other clinical study documentation

• Assess adverse events and serious adverse events from clinical trials as necessary

• Analyze standard safety-data tables, figures, and listings

• Engage in the creation of safety-related data collection forms and participate in study team meetings

• Conduct signal detection, evaluation, and management through the analysis of safety data

• Document activities in the safety information management system

• Author Safety Assessment Reports, safety documents, and regulatory responses in conjunction with the Global Safety Organization (GSO)

• Investigate and review adverse-event data, literature, and other safety-related information for signal detection

• Present recommendations from the Global Safety Team to cross-functional decision-making groups

• Assist in the development of risk-management strategies, plans, risk minimization activities, and responses to regulatory inquiries

• Support safety-related tasks for new drug applications and other regulatory submissions

• Perform delegated Qualified Person Responsible for Pharmacovigilance (QPPV) activities and ensure inspection readiness

• Act as a representative and point of contact for Health Authority Inspections and Internal Process Audits

⛳️ Requirements

• Doctorate degree with 2 years of industry pharmacovigilance experience, OR Master’s degree with 4 years of industry pharmacovigilance experience, OR Bachelor’s degree with 6 years of industry pharmacovigilance experience, OR Associate’s degree with 10 years of industry pharmacovigilance experience, OR high school diploma/GED with 12 years of industry pharmacovigilance experience

• Familiarity with signal detection, evaluation, and management

• Expertise in literature surveillance, including knowledge and skills for source document review

• Proficiency in aggregate data analysis, interpretation, and synthesis

• Strong clinical and scientific judgment

• Experience in clinical and/or medical research

• Knowledge of qualitative and quantitative methods for safety data analysis

• Sponsorship for this position is not assured

🏝️ Benefits

• Retirement and Savings Plan featuring generous company contributions

• Comprehensive group medical, dental, and vision insurance

• Life and disability insurance coverage

• Flexible spending accounts available

• Discretionary annual bonus program

• Stock-based long-term incentive opportunities

• Award-winning time-off policies

• Flexible work arrangements where feasible

• Opportunities for career development

• Support for work/life balance