Director, Pharmacovigilance Operations (MariTide Lead) - Remote

Overview

Join Amgen’s mission to serve patients as the Director of Pharmacovigilance Operations, where you will oversee safety reporting and ensure compliance with global regulations.

In Short

• Act as US/EU local safety office and FDA/EMA point of contact.
• Oversee processing and submission of individual case safety reports.
• Manage vendor oversight for adverse events and product complaints.
• Ensure compliance with global safety legislation.
• Lead process improvement strategies for pharmacovigilance.
• Develop and maintain standard operating procedures.
• Support audit and inspection readiness.
• Communicate plans and objectives across teams.
• Participate in training and development programs.
• Drive compliance and performance metrics.

Requirements

• Doctorate degree and 4 years of Drug Safety experience; or Master’s with 7 years; or Bachelor’s with 9 years.
• 8+ years of relevant experience preferred.
• Experience in leading and managing teams.
• Strong cross-functional communication skills.
• Knowledge of adverse event reporting processes.
• Experience with regulatory compliance.
• Ability to drive process improvements.
• Familiarity with clinical trial data collection.
• Experience in a biotechnology or pharmaceutical environment.
• Strong analytical and problem-solving skills.

Benefits

• Competitive salary and total rewards plan.
• Comprehensive employee benefits package.
• Retirement and savings plan with company contributions.
• Flexible work models including remote options.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.
• Supportive and collaborative work culture.
• Commitment to employee well-being.