Subject Matter Expert E2B R2/R3 Conversion

Job Description:

• We are seeking a highly knowledgeable and experienced Subject Matter Expert (SME) to provide critical expertise and guidance for our transition from the E2B R2 to the E2B R3 format for electronic transmission of Individual Case Safety Reports (ICSRs). The SME will be instrumental in understanding the nuances of both standards, identifying the impact of the conversion on our current systems and processes, and ensuring a smooth and compliant implementation of the E2B R3 requirements. This role requires a deep understanding of pharmacovigilance regulations, data standards, and system integration.

Job Responsibilities:

• Serve as the primary subject matter expert on E2B R2 and R3 data standards and their application within our organization’s pharmacovigilance processes.
• Analyse current E2B R2 data structures, workflows, and system configurations to identify gaps and required changes for R3 compliance.
• Develop a comprehensive understanding of the impact of the E2B R3 conversion on various stakeholders, including data entry teams, safety physicians, regulatory affairs, and IT systems.
• Collaborate with IT teams and vendors to define technical specifications for system modifications and data migration strategies.
• Participate in the development and execution of data mapping exercises between E2B R2 and R3 elements.
• Contributes to the creation and review of validation plans, test scripts, and other quality documentation related to the E2B R3 implementation.
• Provide expert guidance in the development and delivery of training materials for relevant personnel on the new E2B R3 standards and processes.
• Support the resolution of technical and business issues arising during the conversion process.
• Stay abreast of the latest regulatory guidelines and industry best practices related to E2B R3 implementation.
• Participate in project meetings and provide regular updates on progress, risks, and issues related to the E2B conversion.
• Ensure compliance with all applicable global pharmacovigilance regulations and guidelines.

Qualifications:

• Bachelor’s degree in relevant scientific discipline (e.g., Pharmacy, Biology, Nursing) or equivalent experience.
• Minimum of 2-3 years of experience in pharmacovigilance operations, with a strong focus on ICSR processing and electronic reporting.
• Demonstrable in-depth knowledge of the ICH E2B (R2 and R3) guidelines and their practical application.
• Hands-on experience with safety databases (e.g., Argus, ArisG) and electronic gateway submissions is desirable.
• Understanding data mapping principles and experience with data migration projects is highly desirable.
• Familiarity with regulatory submission processes and requirements in major global regions (e.g., EMA, FDA).
• Excellent analytical, problem-solving, and communication skills (both written and verbal).
• Ability to work independently and collaboratively within cross-functional teams