Global Patient Safety Leader

5 days ago

Dublin, Dublin City, Ireland beBeePatient Full time $180,400 - $300,700
Director, Patient Safety Intake and Regulatory Submissions

The Director of Patient Safety Intake and Regulatory Submissions oversees the delivery of Global Patient Safety Department services in accordance with ICH-GCP guidelines, regulatory requirements, and company standard operating procedures. This position is responsible for the oversight of processes and systems that enable initial adverse event data intake and subsequent Individual Case Safety Report submissions to health authorities and internal destinations.

This role leads a global team responsible for all aspects of intake and ICSR submissions for the company product portfolio covering pre and post-marketing activities. The position also involves overseeing and maintaining all reporting rules in the global safety database, Argus.

A typical day in this role may include:

  • ICSR intake and submissions from all sources to all applicable destinations.
  • Oversight of all aspects of intake responsibilities for ICSRs, including vendor management.
  • Oversight of all aspects of ICSR submission, including database configuration and assessment of study particulars and reporting requirements.
  • Review and approval of configuration requests.
  • Provides input into contract deliverables to support outsourced intake and submissions activities.
  • Assists with the review, execution, and implementation of related contract deliverables.
  • Oversight of follow-up activities, including targeted follow-up questionnaires associated with risk management plans or other routine safety data monitoring measures.
  • Review and/or creation of metrics to measure intake and reporting compliance.
  • Training and mentoring of staff on safety information pertaining to intake and ICSR submission processes.
  • Serves as ICSR intake and submission subject matter expert for audits and inspections.
  • Further develops and maintains best practices/processes for high-quality and compliant point-of-contact activities.
Required Skills and Qualifications

To be considered for this opportunity, you must have the following qualifications:

  • 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.
Benefits

We offer an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Others

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

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