Senior Manager, Aggregate Reporting

Role Overview

• Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables
• Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions
• Provides expertise and guidance to authors and contributors of aggregate reports
• Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance
• Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
• Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
• Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
• Acts as subject matter expert during audits and inspection
• Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports
• Acts as a functional vendor management overseeing and driving high quality outputs from our vendors
• Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports’ templates, KPIs
• Drives process improvement through automation and other tech initiatives.

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
• 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 allowing for streamlined process execution

Tech Stack

• Google Cloud Platform
• PMP

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave) for eligible employees at all levels