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Senior Patient Safety Director

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Dublin, Dublin City, Ireland beBeeRegulatory Full time $180,400 - $300,700
Job Title: Director, Patient Safety Intake and Regulatory Submissions

This senior leadership role oversees the delivery of Global Patient Safety Department services according to ICH-GCP guidelines, regulatory requirements and standard operating procedures (SOPs) and/or project specific procedures.

The job holder will be responsible for leading a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities.

The key responsibilities include:

  • Leading a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities.
  • 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 as well as assist with the review, execution, and implementation of related contract deliverables.
  • Performs other related duties as assigned or requested per business needs.

Key qualifications include:

  • 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.
  • Excellent knowledge of Argus and its applications.
  • Strong verbal and written communication skills.
  • Ability to work independently, prioritize effectively and work in a matrix team environment.

The ideal candidate should have excellent leadership and collaboration skills, strong analytical and problem-solving abilities, and the ability to communicate effectively at all levels.

We are an equal opportunities employer and welcome applications from diverse candidates.