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

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