Senior Director, Drug Safety and Pharmacovigilance Operations Lead

10 hours ago


Cambridge, Massachusetts, United States Leap Therapeutics Full time
Job Summary

Leap Therapeutics is seeking a highly experienced Senior Director of Pharmacovigilance and Safety Operations to lead our pharmacovigilance operations and safety strategy. This role will be responsible for overseeing the development and implementation of safety strategies, managing internal and external staff, and ensuring compliance with regulatory guidelines.

Key Responsibilities
  • Develop and implement safety strategies to ensure compliance with regulatory guidelines
  • Manage internal and external staff allocated to pharmacovigilance operations
  • Provide expert guidance and leadership on safety requirements and regulations
  • Oversee the development and implementation of safety systems and databases
  • Ensure compliance with Good Pharmacovigilance Practice (GVP) and ICH guidelines
Requirements
  • Bachelor's or advanced degree in life science, nursing, pharmacy, or other healthcare-related profession
  • Minimum 10 years of experience in pharmacovigilance operations, including 5 years in a management position
  • Experience with safety databases, electronic data capture systems, and electronic document management systems
  • Knowledge of GCPs, ICH guidelines, and FDA, EMA, and other international regulations


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