Education/Experience/Skills: Candidates must hold a Doctor of Medicine (MD) degree from an ECFMG accredited institution, along with a current or former physician medical license issued in one of the countries where the SAB-142 Clinical Development Program is being executed (USA, UK, EU, NZ, or AUS).12+ years of progressive pharmaceutical/biotech industry pharmacovigilance experience, with at least 5 years in a senior role with direct accountability for late-phase global biologics PV programs. Aggregate Safety Reporting & Regulatory Submissions Author and/or oversee the preparation of Integrated Safety Summaries (ISS) and Integrated Summaries of Efficacy (ISE) for BLA and MAA submissions (member of the submission team), ensuring scientific rigor, internal consistency, and full alignment with regulatory expectations (21 CFR 314.50, Module 2.7.4,