Temp Associate Director, Aggregate Reporting

Job Summary

A company is looking for a Temp - Associate Director, Aggregate Reporting, GPS.

Key Responsibilities

• Oversee the development and maintenance of Aggregate Reporting deliverables such as PSURs and DSURs
• Lead planning, production, and distribution activities for aggregate reports across various functions
• Collaborate with Global Patient Safety and other functional areas to ensure timely and high-quality aggregate reports

Required Qualifications

• Bachelor's degree in Life Sciences or related field
• Minimum of 7 years of pharmacovigilance experience focused on aggregate reporting
• Extensive knowledge of US, ICH, EU pharmacovigilance regulations
• Experience with regulatory inspections and audits related to pharmacovigilance
• Medical writing experience with regulatory documentation