Patient Safety Compliance Lead

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time $180,400 - $300,700
Lead Patient Safety Specialist

The Director, Patient Safety Intake and Regulatory Submissions role delivers Global Patient Safety Department services according to ICH-GCP guidelines, regulatory requirements, and standard operating procedures. The position is responsible for overseeing processes and systems for initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners, and internal destinations in compliance with global regulations and contractual obligations.

Key Responsibilities:
  • Oversight of processes and systems for initial intake of adverse event data.
  • Follow-up activities to ensure receipt of complete and accurate safety information.
  • Leadership of a global team responsible for all aspects of Intake and ICSR submissions.
  • Oversight and maintenance of all reporting rules in the global safety database.

As a patient safety specialist, you will work closely with cross-functional teams to ensure compliance with global regulations and standards.

Required Skills and Qualifications:
  • Expert knowledge of tools and systems for data automation, advanced data validation, and analytics.
  • 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.
  • Excellent written and verbal communication skills.
  • Ability to reason independently and assess complex ideas.
  • Attention to detail and ability to identify and resolve discrepancies on compliance reports.
Requirements:
  • Bachelor's Degree in one of the life sciences or clinical research.
  • Minimum of 12 years of experience in safety and safety reporting.
  • Excellent knowledge of Argus and its applications.

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