Pharmacovigilance Signal Detection Lead
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 Medical Writing Manager Ensure 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 ENVIRONMENT Remote: Romania / Poland or Portugal The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. To apply for this role: Step 1: Proceed to follow the form instructions Step 2: Our HR team will review your application with feedback Step 3: If successful, HR will arrange your Introductory call Step 4: A potential online language assessment Step 5: 1st formal interview Step 6: 2nd formal interview Step 7: Offer NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible. 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