Pharmacovigilance Operations Specialist

3 days ago

Dublin, Dublin City, Ireland beBeepharmacovigilance Full time €60,000 - €80,000

Pharmacovigilance Expertise

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We are seeking a highly skilled Pharmacovigilance Advisor to join our team. As a Pharmacovigilance Advisor, you will play a critical role in ensuring the quality and integrity of pharmacovigilance operations.

Key Responsibilities:
  • Maintain adherence to quality systems and pharmacovigilance quality systems.
  • Process cases and report adverse event reports (ICSRs) in a timely manner while maintaining global safety databases.
  • Screen literature for ICSRs and Safety information.
  • Conduct periodic case reconciliations with clients and business partners.
  • Draft and drive PVAs and SDEAs to finalization with clients and business partners.
  • Assist with GVP inspection readiness activities.
  • Investigate non-conformances and CAPA management.
  • Support Pharmacovigilance compliance activities, KPIs, and metric management.
  • Engage in quality system continuous improvement initiatives.
Requirements:
  • Bachelor's degree in Science, Pharmacy, Pharmacology, Nursing, or related field.
  • Minimum 2 years' experience in pharmacovigilance and quality management systems.
  • Commercial awareness and ability to assess commercial implications of decisions.
  • Awareness of Pharmacovigilance legislation in Europe and the UK.
  • Strong project management skills and attention to detail.
  • Excellent interpersonal and communication skills.
  • Motivated self-starter with ability to work independently.

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