Pharmacovigilance Expert

2 weeks ago

Dublin, Dublin City, Ireland beBeePharmacovigilance Full time €55,000 - €80,000
Job Title: Pharmacovigilance Specialist

The successful candidate will join our organization on a permanent full-time contract, with flexibility to work from home and in the office.

This role offers an excellent opportunity for a skilled professional to make a meaningful contribution to our commitment to pharmacovigilance and patient safety.

Key Responsibilities:
  • Ensure adherence to quality management systems and pharmacovigilance processes.
  • Process cases and report ICSRs and maintain global safety databases.
  • 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 clients and business partners.
  • Assist with GVP inspection readiness activities.
  • Investigate non-conformances and CAPA management.
  • Support team with 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 of Science 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.
  • Understanding of pharmacovigilance legislation in Europe and the UK.
  • Strong project management skills and attention to detail.
  • Interpersonal and communication skills with proven ability to influence people.
  • Motivated self-starter with ability to work independently.
  • Confidence to embrace new challenges.
  • Discretion and confidentiality at all times.

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