Pharma Co-vigilance Auditor
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!
- 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
- 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 / email@example.com
Please note, your CV will never be released without your prior consent.