Senior Manager, Aggregate Reporting Management
Core
Managing aggregate safety reporting activities across the product lifecycle, ensuring compliant preparation and submission of periodic and ad-hoc safety reports to health authorities globally.
Role type
Senior Manager, Aggregate Reporting Management
Builds
Periodic safety reports (PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) and ad-hoc safety reports for health authorities, collaborators, and CROs.
Domain
Pharmacovigilance / Pharmaceutical Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aggregate safety reporting expertise, project management, health authority inspection experience, medical writing for regulatory documentation, strategic decision-making, analytical skills, process improvement, vendor management, SOP development.
Preferred skills
Advanced degree, HCP-focused background, PMP certification.
Technologies
Safety and clinical databases, automation tools, process execution technology.
Responsibilities
Drive preparation and maintenance of aggregate reporting deliverables; lead planning, production, and distribution of reports across US, EU, Japan, and other regions; provide expertise and guidance to report authors; maintain compliance metrics and implement CAPA for non-compliance; develop functional specifications for data requirements; collaborate with Epidemiology, Clinical Development, Regulatory Affairs, and Statistics; act as subject matter expert during audits; oversee CRO activities; manage functional vendors; develop procedural packages (SOPs, templates, KPIs); drive process improvement through automation.
Seniority
Senior Manager, hands-on leadership with strategic oversight
