Senior Pharmacovigilance Advisor

2 weeks ago


Dublin, Dublin City, Ireland beBeePharmacovigilance Full time €60,000 - €75,000
Job Description:

We are seeking a skilled Pharmacovigilance Specialist to join our team on a permanent full-time contract. The successful candidate will be responsible for case processing and timely reporting of ICSRs, as well as screening local and global literature for safety information.

Key responsibilities include maintaining global safety databases, conducting periodic case reconciliations with clients, and drafting and finalizing PVAs and SDEAs.

Key Accountabilities & Responsibilities:
  • Adhere to the Quality System and Pharmacovigilance Quality System
  • Process cases and report ICSRs in a timely manner
  • Screen literature for safety information
  • Conduct periodic case reconciliations with clients
  • Draft and finalize PVAs and SDEAs
  • Assist with GVP inspection readiness activities
  • Assist with non-conformance and CAPA management
  • Support compliance activities, KPIs, and metric management
Attributes & Experience Required:
  • B.Sc. in Science, Pharmacy, Pharmacology, Nursing, or related discipline
  • Minimum 2 years' experience in pharmacovigilance and quality management systems
  • Commercial awareness and ability to assess commercial implications of decisions
  • Awareness and understanding of Pharmacovigilance legislation in Europe and the UK
  • Strong project management skills and attention to detail
  • Excellent interpersonal and communication skills


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