Associate Director, R&D Quality Good Pharmacovigilance Practice

Responsibilities

• Conduct and support quality assurance activities related to Pharmacovigilance regulations and guidelines
• Lead PV inspection readiness activities and regulatory inspection management
• Develop and enhance quality systems and processes for effective risk management
• Manage routine and for-cause audits of vendors and partners, ensuring compliance with industry standards
• Oversee quality management risk plans and conduct management reviews for quality assurance
• Coincide with cross-functional cooperation with departments like Patient Safety, Regulatory Affairs, and Clinical Operations
• Participate as a backup for the Head, GVP QA to maintain the accountability of quality systems

Qualifications

• Bachelor of Science degree with 8+ years in Pharmacovigilance required, Master's degree with 6+ years preferred
• In-depth knowledge of global Pharmacovigilance (GVP) and Good Clinical Practice (GCP) requirements
• In-depth understanding of international regulations for clinical trials and pharmacovigilance operations
• Experience leading within a matrixed global organization, managing people and processes
• Strong problem-solving skills with ability to analyze complex data and situations effectively
• Prominent track record in driving quality improvements and revising Standard Operating Procedures (SOPs)

Benefits

• Comprehensive medical, dental, and vision insurance
• 401(k) plan participation and flexible spending accounts (FSA/HSA)
• Life insurance and generous paid time off policies
• Employee stock purchase plan and discretionary equity awards available