Chief Pharmacovigilance Officer

2 days ago

Dublin, Dublin City, Ireland beBeePharmacovigilance Full time €50,000 - €70,000

**Job Summary**

We are seeking a skilled Pharmacovigilance Specialist to join our client's team on a permanent full-time contract. The successful candidate will be responsible for adhering to the Quality System and Pharmacovigilance Quality System, case processing, and timely reporting of ICSRs.

Key Responsibilities:
  • Adhere to the Quality System and Pharmacovigilance Quality System
  • Process cases and report ICSRs in a timely manner
  • Screen literature for ICSR reports and safety information
  • Conduct and monitor periodic case reconciliations with clients and partners
  • Draft and finalize PVAs and SDEAs with clients and partners
  • Assist with GVP inspection readiness activities
  • Investigate non-conformances and manage CAPA initiatives
  • Engage in quality system continuous improvement projects
  • Support client audits and authority inspections
  • Prepare signal detection reports and other critical documents
Requirements and Qualifications:
  • Bachelor's degree in Science, Pharmacy, Pharmacology, Nursing, or related field
  • Minimum 2 years' experience in pharmacovigilance and quality assurance
  • 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 take on new challenges and responsibilities
  • Maintain confidentiality and handle sensitive information

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