Pharmacovigilance Lead Signal Detection

Job description

Pharmacovigilance Lead Signal Detection  Summary:  The Pharmacovigilance Lead Signal Detection is a 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 integrating data from spontaneous reports, clinical trials, post-authorization safety studies, scientific literature, social media monitoring, as applicable - Prepare and review signal...