Associate Director, Operations Patient Safety and Pharmacovigilance - Remote

Overview

The Associate Director, Operations Patient Safety and Pharmacovigilance is responsible for safety operations and vendor oversight activities, ensuring compliance and inspection readiness while supporting the company's growth.

In Short

• Manage safety operations and vendor oversight activities.
• Support vendor management and compliance strategies.
• Collaborate with internal stakeholders for efficient operations.
• Oversee ICSR case management workflow with safety vendors.
• Lead site query activities for serious adverse events (SAEs).
• Support clinical trial study teams with safety operational needs.
• Ensure inspection readiness and support global filing activities.
• Recruit, mentor, and manage direct reports.
• Participate in process improvement and gap assessments.
• Act as a subject matter expert for internal audits.

Requirements

• Bachelor’s degree in nursing, pharmacy, or healthcare-related fields.
• 6+ years in Safety and Pharmacovigilance in the pharmaceutical industry.
• 4+ years managing contracted safety vendors.
• Oncology experience preferred.
• Strong knowledge of drug safety database systems and MedDRA.
• Operational expertise in ARGUS required.
• Excellent communication and project management skills.
• Ability to work in a dynamic, fast-paced environment.
• Knowledge of FDA, EMA, and Asia-PAC legislation.
• Demonstrated ability to collaborate with cross-functional teams.

Benefits

• Competitive salary range of $185,000 - $200,000 annually.
• Opportunity to participate in stock programs.
• Performance-based bonus structure.
• Comprehensive benefits package.
• Equal Opportunity Employer committed to diversity.
• Support for employee growth and development.
• Flexible work arrangements including remote options.
• Engaging and collaborative work environment.
• Access to resources for professional advancement.
• Commitment to employee well-being and work-life balance.