Safety Leader

2 days ago

Dublin, Dublin City, Ireland beBeeLeadership Full time $180,400 - $300,700

Job Description:

Director, Patient Safety Intake and Regulatory Submissions

The Director of Patient Safety Intake and Regulatory Submissions plays a critical role in delivering Global Patient Safety Department services according to ICH-GCP guidelines, regulatory requirements, and company standard operating procedures (SOPs). This position is responsible for overseeing the processes and systems that enable initial intake of adverse event data, subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, alliance partners, and internal destinations. The role involves ensuring compliance with applicable global regulations and contractual obligations.

Responsibilities:
  • Oversight of all aspects of intake responsibilities for ICSRs, including management of applicable vendors.
  • Provides input into contract deliverables to support outsourced intake and submissions activities.
  • Assists with the review, execution, and implementation of related contract deliverables.
  • Reviews and/or creates metrics to measure intake and reporting compliance to regulatory agencies, alliance partners, internal destinations, and contract research organizations.
  • Serves as ICSR intake and submission subject matter expert (SME) for audits and inspections.
Requirements:
  • 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.
Preferred Qualifications:
  • 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.
Benefits:

Regeneron offers a comprehensive benefits package, which includes health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Company Culture:

Regeneron has an inclusive and diverse culture that provides opportunities for growth and development.

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