Lead Safety Systems E2B Specialist (Contract to hire)

Role Overview

The Lead Safety Systems E2B Specialist (Contract) will provide hands-on leadership and subject matter expertise for E2B (R2/R3) electronic safety reporting within the company's safety systems landscape. This role is responsible for owning E2B requirements, validation, and regulatory compliance, while partnering closely with internal pharmacovigilance, regulatory, quality, and IT teams to ensure accurate, compliant, and timely safety data exchange.

Key Responsibilities:

E2B Ownership & Leadership

• Act as the primary E2B SME for the company's safety system(s).
• Own end-to-end E2B reporting processes, standards, and system configurations.
• Lead regulatory impact assessments and readiness for E2B-related changes.

Requirements & Configuration

• Lead analysis and documentation of E2B(R2/R3) ...