Associate Director, Medical Safety Surveillance - Remote

Overview

This position supports the Clinical Trial Patient Safety (CTPS) organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality, relevant and timely data review.

In Short

• Responsible for world-wide surveillance of clinical trial patient safety data.
• Manages operational areas related to clinical safety adverse event surveillance.
• Establishes and communicates workload projections and metrics.
• Supports training programs and staff development.
• Assists in strategic planning and department development.
• Applies knowledge of ICH, FDA, EMA regulations to CTPS processes.
• Partners with medical monitors for oversight of medical safety reviews.
• Provides oversight of narrative deliverables and document management systems.
• Implements and improves department SOPs.
• Manages a team of 5 to 10 people.

Requirements

• Bachelor’s degree in health science; advanced degree preferred.
• 10 years of experience, including clinical practice and drug safety.
• Experience in direct management capacity preferred.
• Significant experience leading cross-functional teams.
• Subject matter expertise in industry regulations and clinical safety.
• Proficient in computer applications and databases.
• Excellent communication and leadership skills.
• Strong influencing skills and ability to manage complex issues.
• In-depth understanding of product safety profiles.

Benefits

• Comprehensive benefits package including paid time off.
• Medical, dental, and vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term and long-term incentive programs.