Senior Manager, Aggregate Reporting Management

Responsibilities Manage aggregate safety reporting activities across all phases of the product lifecycle, supporting consistent, compliant, scientifically robust preparation, distribution, and submission of periodic and ad‑hoc safety reports. Drive preparation, development, and maintenance of aggregate reporting deliverables (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs). Lead aggregate report planning, production, and distribution across GPS and other functions for US, EU, Japan, and other ICH regions, plus non‑ICH regions. Provide expertise and guidance to authors and contributors of aggregate reports. Maintain compliance metrics and contribute to quality events and CAPA implementation for non‑compliance. Implement structure, procedures, and tools to ensure timely, high‑quality completion of aggregate reports and related deliverables. Develop and oversee functional specifications of data requirements for aggregate deliverables from safety and clinical databases. Collaborate with GPS and cross‑functional teams (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) to contribute to aggregate safety reports. Serve as subject matter expert during audits and inspections. Provide oversight and training to CRO activities supporting high‑quality, timely aggregate reports. Provide functional vendor management to ensure high‑quality vendor outputs. Develop and maintain aggregate report procedural packages (SOPs, work instructions), templates, and KPIs. Drive process improvement through automation and technology initiatives. Qualifications / Requirements Bachelor’s degree required; advanced degree or HCP‑focused background preferred. 5+ years of pharmacovigilance experience with a demonstrated focus on aggregate safety reporting. Project management experience strongly preferred; PMP preferred. Experience with health authority inspections (PV and GCP). Medical writing experience with regulatory documentation. Preferred Skills Strong project management skills. Excellent strategic decision‑making and analytical skills. Strong communication and writing skills. Strong understanding of scientific content. Proven experience with technology implementations to streamline process execution. #J-18808-Ljbffr