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Pharma Co-Vigilance Auditor – Galway

Pharma Co-vigilance Auditor
County Galway

My client, who specialize in the manufacture and supply of generic pharmaceuticals have a vacancy at the moment in County Galway. This company has significant operations in multiple countries and are keen to speak with Pharma Co-vigilance personnel!

Salary and full job description available upon request!

Responsibilities:

  • Conduct pharmacovigilance audits, according to the agreed Audit Programme and in line with agreed Audit plan and Quality plan
  • Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines
  • Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis
  • Generate and monitor audit metrics and performance evaluation
  • Act as Lead Auditor on an assigned audit basis: Review performance of pharmacovigilance audits, ensuring that audits comply with local and global regulatory requirements as well as contractual agreements
  • Support audits and inspections of the company performed by clients/third parties and regulatory authorities;
  • Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of the company
  • Keep up-to-date with the relevant regulations, legislation of Pharmacovigilance, participate in relevant seminars and trainings

Requirements:

  • Degree in life sciences or healthcare
  • Strong experience in Pharmacovigilance
  • Previous auditing experience
  • Knowledge of EU Regulations as well as Guidelines on GVP and ICH Guidelines
  • Quality-oriented, quality-committed
  • Excellent interpersonal and communication skills, including good presentation and report writing skills
  • Fluent knowledge of English; additional languages would be a plus

For more information and to discuss similar opportunities, contact Lee on 0858072559 / lee@optimizerecruitment.ie
Please note, your CV will never be released without your prior consent.

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