Senior Manager, Aggregate Reporting Management

About the role

The Senior Manager, Aggregate Reporting Management plays a crucial role in the Global Patient Safety (GPS) Operations team. They manage aggregate safety reporting activities across all phases of the product lifecycle, ensuring compliance and scientific robustness in the preparation, distribution, and submission of periodic and ad-hoc safety reports to health authorities, collaborators, and contract research organizations worldwide.

Responsibilities

• 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.
• Expertise & Guidance: Provides expertise and guidance to authors and contributors of aggregate reports.
• Compliance Metrics: Maintains compliance metrics and contributes to the implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance.
• Structure & Tools: Implements effective structure, procedures, and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality.
• Data Requirements: Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases.
• Collaboration: Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports.
• Audits & Inspections: Acts as a subject matter expert during audits and inspections.
• Vendor Management: Oversees and drives high-quality outputs from our vendors in support of CRO activities.
• Process Improvement: Develops and maintains aggregate report procedural packages (SOPs, Work Instructions), reports templates, KPIs, and drives process improvement through automation and other tech initiatives.

Requirements

• Bachelor’s degree required (advanced degree or HCP-focused background preferred) and 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.
• Proven experience with technology implementations allowing for streamlined process execution.