Senior Drug Safety Specialist

2 weeks ago

Nenagh, County Tipperary, Ireland beBeePharmacovigilance Full time €60,000 - €70,000
Job Opportunity

We are seeking an experienced Pharmacovigilance Advisor to join our team in the Pharmacovigilance Department.

This is a permanent full-time contract opportunity that offers flexibility and hybrid working arrangements, allowing you to balance remote work with onsite attendance at our offices.

Key Responsibilities:
  • Ensure adherence to established quality systems.
  • Process cases and report ICSRs and maintain global safety databases in a timely manner.
  • Screen local and global literature for ICSRs and safety information.
  • Conduct periodic case reconciliations with clients and business partners.
  • Draft and finalize PVAs and SDEAs with all clients and partners.
  • Support GVP inspection readiness activities.
  • Investigate non-conformances and CAPA management.
  • Maintain Pharmacovigilance compliance activities, KPIs, and metric management.
  • Engage in quality system continuous improvement initiatives.
  • Support client audits and authority inspections.
  • Prepare signal detection reports, RMPs, PSURs, and PSMFs.
Required Attributes and Experience:
  • Bachelor's degree in Science, Pharmacy, Pharmacology, Nursing, or related field (minimum).
  • A minimum of 2 years' experience in pharmacovigilance and quality management systems.
  • Commercial awareness and ability to assess commercial implications.
  • 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.
  • Confidence to embrace new challenges within qualifications and experience.
  • Maintain client confidentiality and observe discretion.
Benefits:
  • Flexibility and hybrid working arrangements.
  • Persistent learning opportunities.
  • Closed collaboration with a professional team.

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