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 FunctionsLead 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 applicablePrepare 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 activitiesDevelop and review SOPs and Work Instructions related to signal management in collaboration with the PV Quality Manager and the PV Medical Writing ManagerEnsure inspection and audit readiness and actively support QA activities including CAPA follow-up.Interact with the PV Physician and QPPV for scientific exchange pertaining to signal assessment and benefit-risk implications.Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements.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, VigiBase) required.Computer Skills:Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), signal detection tools, literature databases (Embase,PubMed), Microsoft Office Suite. Familiarity with statistical tools is an advantage.WORK ENVIRONMENTRemote: Romania / Poland or Portugal
4 months ago