Experienced Pharmacovigilance Professional Wanted

2 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €55,000 - €75,000

Job Description

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We are seeking an experienced Pharmacovigilance Advisor to join our team. The successful candidate will be responsible for providing high-quality pharmacovigilance support, ensuring adherence to quality systems and regulations.

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Key Accountabilities & Responsibilities:

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  • Case processing and timely reporting of ICSRs and maintenance of global safety databases.">
  • Screening of local and global literature for ICSRs and safety information.">
  • Conduct and monitor periodic case reconciliations with clients and business partners.">
  • Drafting PVAs and SDEAs and driving them to finalization with clients and business partners.">
  • Assist with GVP inspection readiness activities.">
  • Assist in the writing and investigation of non-conformances and CAPA management.">
  • Support the company during client audits and authority inspections.">
  • Prepare signal detection reports, RMPs, PSURs, and PSMFs.">
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Required Skills and Qualifications:

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  • Bachelor's degree in Science, Pharmacy, Pharmacology, Nursing, or related field.">
  • A minimum of 2 years' experience working within pharmacovigilance and quality management systems and procedures.">
  • Commercial awareness and ability to assess commercial implications of decisions and advice.">
  • Awareness and understanding of pharmacovigilance legislation in Europe and the UK.">
  • Good project management skills with a systematic approach to tasks.">
  • Ability to keep meticulous records and strong attention to detail.">
  • Strong interpersonal and communication skills with proven ability to influence people internally and externally.">
  • Motivated self-starter with ability to work independently.">
  • Confidence to embrace new challenges within qualifications and experience.">
  • Maintain client confidentiality and observe discretion at all times.">
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Benefits:

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  • Flexibility/hybrid working arrangement available combining remote working at home with onsite attendance in offices.">
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Others:

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  • Must have legal right to work in Ireland at time of application.">
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