Senior Manager, Global Pharmacovigilance Safety – Obesity

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

📋 Description

• Collaborate with Therapeutic Safety Teams on safety assessment initiatives for medical and scientific operations.

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

• Coordinate and direct liaison efforts with affiliates and internal Amgen partners concerning products.

• Support and supervise staff in clinical trial safety activities.

• Evaluate study protocols, statistical analysis plans, and documents related to clinical studies.

• Assess adverse events and serious adverse events arising from clinical trials.

• Analyze safety data tables, figures, and listings.

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

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

• Record activities in the safety information management system.

• Write Safety Assessment Reports, safety documentation, and regulatory responses.

• Investigate and review adverse-event data, literature, and other relevant safety data for signal detection.

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

• Assist with strategies for risk management, planning, risk minimization activities, and responding to regulatory inquiries.

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

• Ensure inspection readiness and act as a liaison 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.

• 2 years of managerial experience in directly managing personnel or projects and/or providing mentoring.

• Experience in clinical or medical research.

• 6 years of experience within the biotech or pharmaceutical industry.

• Sponsorship for this position is not assured.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision insurance.

• Life and disability insurance coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.