Pharmacovigilance Signal Detection Lead

Pharmacovigilance Signal Detection Lead

Senior expert responsible for leading and executing signal detection and evaluation activities across assigned client portfolios. The role combines scientific and epidemiological expertise with operational oversight of signal management workflows, ensuring that emerging safety signals are identified, assessed, prioritized, and communicated in compliance with applicable regulatory requirements (EMA GVP Module IX, ICH E2E, FDA) and client-specific procedures. The Signal Management Lead serves as the subject matter expert for signal-related activities and collaborates closely with medical reviewers, project leads, and client stakeholders.

Essential Functions

• Lead the design, execution, and oversight of signal detection activities, including quantitative analyses (PRR, ROR, EBGM) applied to spontaneous reporting databases (FAERS, EudraVigilance, VigiBase).
• Conduct qualitative signal evaluation integra...