JobMesh

Pharmacovigilance Lead Signal Detection

Med Communications · Cluj-Napoca, Cluj County, RO

Pharmacovigilance Signal Detection Lead Summary The Pharmacovigilance Signal Detection Lead is a senior expert responsible for leading and executing signal d...

Job description

Pharmacovigilance Signal Detection Lead Summary: The Pharmacovigilance Signal Detection Lead 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. Education: Advanced degree in pharmacy (PharmD preferred), medicine, life sciences, or epidemiology. A postgraduate qualification in pharmacoepidemiology or drug safety is an advantage. Experience: Minimum 4 years of PV experience, with at least 2 years focused on signal detection or pharmacoepidemiology at a PV vendor, CRO, or pharmaceutical company. Hands-on experience with signal detection methods and regulatory safety databases (FAERS, EudraVigilance...