Jacqueline Luca, RN BSN

Seasoned Pharmacovigilance (PV) Leader and Registered Nurse with over 20 years of progressive experience in global drug safety operations across sponsor (16 years), CRO, and consulting environments. Strong understanding of global PV regulatory requirements, with proven expertise in clinical trial oversight, and outsourced PV model governance. Adept at managing global PV programs, authoring key regulatory documents, and leading cross-functional safety initiatives to ensure data integrity and patient safety. Recognized for strategic leadership, process optimization, and mentorship of PV professionals in both established and emerging biotech settings.

• Authored preliminary clinical study report (CSR) framework to support data integration and finalization post–top-line results
• Contributed to the authoring of an Integrated Summary of Safety (ISS)
• Directed training and oversight of ~70 vendor personnel at the first CRO performing ICSR processing for newly outsourced products, ensuring quality and compliance.
• Led PV Data Cleansing Team and authored UAT validation scripts to ensure data integrity and readiness for safety data migration
• Established a new and more efficient workflow for processing ICSRs
• Conducted in-depth review and data mining of clinical safety data to detect and reconcile missing or misclassified SAEs, strengthening the integrity of the safety dataset.
• Led the search and evaluation process for a post-marketing PV vendor, conducting due diligence and meetings with CRO executives to determine best-fit partners.
• Analyzed clinical and regulatory data to determine feasibility and requirements for expanding product indication
• Conducted targeted review of non-serious AE reports from under-reporting clinical sites to detect and reconcile potential missing SAEs

• Processing ICSRs, including duplicate searches, full data entry of source data, assessment of seriousness, listedness, and relatedness, MedDRA and WHO Drug coding, and preparation of narratives, for investigational, spontaneous, legal and literature cases.
• Performing quality review of ICSRs
• Facilitating the analysis of similar events for expedited safety reports
• Creating and managing queries to sites, providers and consumers
• Submitting ICSRs/SUSARs to partners and regulatory authorities globally
• Executing SAE reconciliations with clinical and partners
• Preparing RFIs and RFPs for potential vendors
• Providing safety guidance and input for key documents, including IBs, ICFs, protocols, study reports, and RMPs
• Authoring and providing PV operational expertise in development of SMPs, SDEAs, PV agreements, aggregate reports, SOPs, AE report forms, PV job descriptions, and training curricula
• Contributing to signal detection activities, including data analysis and evaluation of safety signals to identify potential risks
• Identifying opportunities for process optimization and implementing innovative solutions to enhance PV operations
• Fielding, prioritizing and responding daily to questions, concerns, and issues raised by CRO staff
• Monitoring Key Performance Indicators (KPIs) and vendor progress reports
• Initiating actions necessary to address areas of vendor non-compliance and assessing the need for program/vendor retirement
• Reviewing/approving late case comments, CAPAs, and requests for case deletions, nullifications and merges
• Ensuring timely and compliant case processing operations in collaboration with vendors
• Working cross-functionally with RA, Clinical Operations, DM, QA, and MA to ensure appropriate PV processes are in place and adhered to
• Supporting PV audit and inspection activities, as required, and serving as SME during these activities