Pharmacovigilance Quality Assurance Specialist

1 week ago

Cork, Cork, Ireland beBee Careers Full time
Senior Associate/Principal Associate - Pharmacovigilance Quality Assurance Role

This position plays a crucial role in ensuring the quality and integrity of our global medicines. As a Senior Associate/Principal Associate, you will be responsible for implementing and managing quality systems to support business goals and objectives.

Your key responsibilities will include contributing to the development of Global Patient Safety procedures, recommending new quality system documents or changes to existing ones, and providing consultation on the interpretation and practical application of external requirements, standards, and procedures.

You will also be responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed. Additionally, you will consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.

Main Responsibilities:

  • Implement and manage quality systems to ensure compliance and quality oversight of business areas.
  • Develop and maintain quality plans and procedures to support business objectives.
  • Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
  • Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
  • Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.

Key Skills and Qualifications:

  • Bachelor's Degree in a science/health care related field or equivalent work experience.
  • Demonstrated ability to apply quality systems within a regulated work environment.
  • Effective project and time management skills.
  • Knowledge of GCP, ICH, FDA and other regulatory requirements.
  • Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
  • Demonstrated ability to prioritize and handle multiple concurrent tasks.
  • Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies.

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