Associate Director of Clinical Quality

Job Summary

A company is looking for an Associate Director, Clinical Program Quality.

Key Responsibilities

• Develop, review, and maintain signal detection and management processes in compliance with regulations
• Represent the pharmacovigilance department in cross-functional teams and ensure compliance with global regulations
• Lead training and mentorship for team members on signal detection processes and oversee vendor activities

Required Qualifications

• Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or a related field with at least 5 years of relevant experience
• Strong leadership and strategic decision-making skills
• In-depth knowledge of clinical trial methodology and pharmacovigilance regulations
• Experience with safety data collection, interpretation, and preparation of regulatory reports
• Proficiency in Microsoft Word, Excel, and PowerPoint