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. 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 detection
reports, signal evaluation reports, and signal management plans per
client SOPs and regulatory expectations. Ensure signal management
activities are completed and reported within regulatory timelines
to the appropriate entities (EMA, FDA, UK MHRA). Oversees
systematic medical literature searches (Embase, PubMed) and
supervise triage and assessment of results for signal-relevant
publications and ICSRs. Collaborate with the aggregate reporting
team on signal-related sections of PSURs/PBRERs and DSURs.
Contribute to Risk Management Plans (RMPs) and REMS as required.
Lead, supervise, and mentor PV Specialists and Sr. PV Specialists
assigned to signal detection activities Develop and review SOPs and
Work Instructions related to signal management in collaboration
with the PV Quality Manager and the PV

📌 Pharmacovigilance Signal Detection Lead (Lombardia)
🏢 Med Communications International
📍 Lombardia