Director, Pharmacovigilance Intake and Regulatory Submissions

Role Summary

The Director, Pharmacovigilance Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position oversees processes and systems enabling initial intake of adverse event data and the reporting of ICSRs to health authorities, Alliance Partners, and internal destinations in compliance with global regulations and contractual obligations. The role 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 all reporting rules in the global safety database, Argus.

Responsibilities

• ICSR Intake and Submissions from all sources to applicable destinations, leveraging tools and systems for data automation, validation, and analytics
• Oversight of Intake responsibilities for ICSRs, including management of applicable vendors
• Oversight of ICSR submission activities including database configuration and assessment of study particulars and reporting requirements across global regulations
• Provide input into contract deliverables to support outsourced Intake and Submissions activities and assist with review, execution, and implementation of related contract deliverables
• Oversee follow-up activities including issuance of targeted follow questionnaires related to risk management plans and routine safety data monitoring
• Develop and review metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations, and CROs
• Train and mentor staff on safety information related 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 and compliant workflows
• 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
• 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 a vehicle

Skills

• Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes
• People management and mentoring experience
• Knowledge of intake and reporting platforms/tools (e.g., LifeSphere Advanced Intake, PVIT)
• Ability to identify and document regulatory non-compliance
• Strong analytical and problem-solving abilities; attention to detail
• Professionalism and strong customer service mindset
• Ability to organize, plan, and execute projects, including delegation and guidance of others