Director, Patient Safety Intake and Regulatory Submissions

Role Summary

Director, Patient Safety Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron SOPs and/or project-specific procedures. This role oversees processes and systems for initial intake of adverse event data, subsequent reporting of ICSRs to health authorities and internal destinations in compliance with global regulations and contractual obligations, and follow-up to ensure complete and accurate safety information. Leads a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio across pre- and post-marketing activities, and maintains reporting rules in the global safety database, Argus.

Responsibilities

• ICSR Intake and Submissions from all sources to all applicable destinations, utilizing tools and systems for data automation, validation, and analytics.
• Oversee Intake responsibilities for ICSRs, including vendor management.
• Oversee ICSR submission processes including database configuration and assessment of study particulars and reporting requirements across global regulations; approve configuration requests.
• Contribute to contract deliverables to support outsourced Intake and Submissions activities and assist with review, execution, and implementation of related contracts.
• Oversee follow-up activities, including issuance of targeted follow questionnaires related to risk management plans and other safety data monitoring obligations.
• Review or create metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations, and CROs.
• Train and mentor staff on safety information pertaining to Intake and ICSR submission processes.
• Serve as ICSR Intake and Submission SME for audits and inspections.
• Develop and maintain best practices/processes for high-quality, compliant operations.
• Act as point of contact for queries from external or internal stakeholders.
• Perform other related duties as assigned per business needs.

Qualifications

• Bachelor's Degree in life sciences or clinical research and/or a licensed healthcare professional required.
• Minimum of 12 years of experience in safety and safety reporting.
• Equivalent combination of relevant education and experience.
• Computer literacy and experience with Microsoft Office (Word, Excel, PowerPoint) required.
• Excellent knowledge of Argus and its applications.
• Excellent verbal and written communication skills; ability to express complex ideas.
• Excellent interpersonal and organizational skills.
• Ability to work independently, prioritize effectively, and work in a matrix team environment.
• Ability and willingness to travel domestically as required; ability to rent automobile.

Skills

• Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes.
• Experience in intake and reporting platforms/tools (e.g., LifeSphere Advanced Intake, PVIT).
• Ability to identify and document regulatory non-compliance and related issues.
• Excellent organizational, problem-solving, and stakeholder management skills.
• Professional demeanor and strong customer service orientation.
• Ability to organize, plan, and execute projects, including delegation and guidance of others to meet timelines and quality standards.

Education

• Bachelor's Degree in life sciences or clinical research and/or a licensed healthcare professional required.

Additional Requirements

• Ability to travel domestically as required; ability to rent a vehicle.