Aptask Global Workforce (AGW) is seeking a Senior Associate, Pharmacovigilance Operations for a Remote position with a Global Biotechnology Company. This is a 6-month contract opportunity.

This role is focused on supporting the safety surveillance process by performing follow-up activities for individual case safety reports. The ideal candidate will ensure vendor compliance, oversee case quality, and act as a point of contact for case processing and reporting to regulatory agencies like the FDA and EMA.

Responsibilities:

• Perform case review


• Support the development and delivery of convention-related training material


• Ensure compliance of reporting activities with timelines and criteria


• Interface with local office staff, CROs and business partners for case processing issues as necessary


• Provide E2B submission support (nullification, redistributi...