Regeneron · 22 hours ago
Director, Pharmacovigilance Intake and Regulatory Submissions
United States
Full-time
Remote
Director/Executive
$180K/yr - $301K/yr
12+ years expRegeneron is a biopharmaceutical company focused on developing life-transforming medicines. They are seeking a Director for Pharmacovigilance Intake and Regulatory Submissions to oversee the intake of adverse event data and ensure compliance with global regulations for safety reporting. This role will also lead a global team and maintain the reporting rules in the safety database.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
ICSR Intake and Submissions from all sources to all applicable destinations. This includes, but is not limited to expert knowledge of tools and systems that allow for data automation, advanced data validation, and analytics
Oversight of all aspects of Intake responsibilities for ICSRs, including management of applicable vendors
Oversight of all aspects of ICSR submission including database configuration and assessment of study particulars and reporting requirements across current global regulations and approval of configuration requests
Provides input into contract deliverables to support outsourced Intake and Submissions activities as well as assist with the review, execution, and implementation of related contract deliverables
Oversight of the all follow up activities including but not limited to the issuance of targeted follow questionnaires associated with risk management plans or other routine safety data monitoring measures and obigations
Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations and contract research organizations
Training and mentoring of staff on safety information pertaining to Intake and ICSR submission processes
Serve as ICSR Intake and Submission subject matter expert (SME) for audits and inspections
Ability to further develop and maintain best practices/processes for high quality and compliant
Point of contact for queries from external or internal stake holders
Performs other related duties as assigned or requested per business needs
Qualification
Required
Bachelor's Degree in one of the 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 working with Microsoft Office (Word, Excel, PowerPoint) required
Excellent knowledge of Argus and its applications
Excellent verbal and written communication skills required
Excellent interpersonal and organizational skills required
Ability to work independently, prioritize effectively and work in a matrix team environment required
Ability and willingness to travel domestically as required; ability to rent automobile
Preferred
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, etc.)
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
Excellent organizational and interpersonal skills
Ability to reason independently to assess and recommend specific solutions in a clinical setting
Attention to detail; able to identify and resolve discrepancies on compliance reports
Demonstrates professionalism and presents a positive image of the company
Demonstrates excellence in customer service, both internally and externally
Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties
Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people
Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect
Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-09
2026-01-08
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