Director, Pharmacovigilance Intake and Regulatory Submissions

1w1 week ago

Regeneron

US · Full-time · $180,400 – $300,700

About this role

The Director delivers Global Patient Safety services per ICH-GCP guidelines, regulatory requirements, and Regeneron SOPs or project procedures. This role oversees processes and systems for initial intake of adverse event data via electronic database capture, phone lines, and more. It ensures compliant reporting of Individual Case Safety Reports to health authorities, Alliance Partners, and internal destinations.

A typical day involves ICSR intake and submissions from all sources using tools for data automation, advanced validation, and analytics. Oversight covers intake responsibilities including vendor management, submission processes with database configuration, and assessment of global reporting requirements. Additional tasks include follow-up activities, metrics creation for compliance, and serving as point of contact for queries.

This position leads a global team handling all aspects of intake and ICSR submissions for pre- and post-marketing product portfolio. Responsibilities extend to maintenance of reporting rules in the Argus global safety database. Input into contracts supports outsourced activities and implementation of deliverables.

The role offers opportunities to train and mentor staff, develop best practices for high-quality compliant processes, and act as subject matter expert for audits and inspections. It emphasizes oversight of follow-up measures like targeted questionnaires tied to risk management plans. Continuous improvement ensures complete and accurate safety information receipt.

Requirements

Independently identify, analyze, and problem solve moderate to complex issues and trends
Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes
Previous people management experience with the ability to mentor and develop direct reports
Strong knowledge of intake and reporting platforms, tools, and systems (i.e. LifeSphere Advanced Intake, PVIT)
Thorough understanding of the global regulatory requirements and the importance of compliance with procedural documents and regulations
Excellent written and verbal communication skills able to express complex ideas
Able to develop knowledge of protocol, regulatory requirements, and company SOPs
Able to identify and document regulatory non-compliance and any related issues

Responsibilities

Oversee ICSR Intake and Submissions from all sources to applicable destinations using tools for data automation, validation, and analytics
Manage all aspects of Intake responsibilities for ICSRs, including applicable vendors
Oversee ICSR submission including database configuration, assessment of study particulars and reporting requirements, and approval of configuration requests
Provide input into contract deliverables to support outsourced Intake and Submissions activities and assist with review, execution, and implementation
Oversee all follow-up activities including issuance of targeted follow-up questionnaires associated with risk management plans or safety data monitoring obligations
Review and/or create metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations, and contract research organizations
Train and mentor staff on safety information pertaining to Intake and ICSR submission processes
Serve as ICSR Intake and Submission subject matter expert for audits and inspections