Pharmacovigilance Compliance Specialist

hace 3 semanas

Madrid, Madrid, España Empresa Reconocida A tiempo completo
Job Description

**About the Role**

We are seeking a highly skilled Pharmacovigilance Auditor to join our team at Empresa Reconocida. As a Pharmacovigilance Auditor, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance services.

Key Responsibilities

  • Conduct audits of our partners and vendors/service providers to ensure compliance with regulatory requirements.
  • Internal audits of projects and processes to identify areas for improvement.
  • Audits of third parties on behalf of our clients to ensure compliance with their specifications.
  • Document audit findings and recommendations, and identify process improvement initiatives.
  • Plan, create, and maintain corrective and preventative action plans as needed.
  • Act as lead auditor on assigned audits, managing audit teams and ensuring compliance with applicable procedures and regulatory requirements.

Requirements

  • Bachelor's degree in a scientific field, preferably healthcare-related.
  • Minimum 4 years of experience in pharmaceutical and/or biotech pharmacovigilance, with a strong understanding of GVP-related quality management and assurance.
  • 2 years of experience in GxP auditing, with a minimum of 1 year in an audit lead role.
  • In-depth knowledge of applicable GxP regulations, including EU and FDA regulations.
  • Strong analytical, written, and oral communication skills.
  • Ability to manage tasks and deliverables in a timely manner, with a proactive approach to problem-solving.
  • Strong team player with a strategic thinking approach.

What We Offer

  • Training and career development opportunities.
  • Strong emphasis on personal and professional growth.
  • Friendly, supportive working environment.
  • Opportunity to work with colleagues based all over the world, with English as the company language.

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