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Job Location | Great Abington |
Education | Not Mentioned |
Salary | Not Mentioned |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
*Pharmacovigilance Compliance Manager / Auditor - Global BioPharma - 12-month contract * My client is a Global Biopharmaceutical company that is focused on the development and discovery of innovative medicines and they have a position available for a Pharmacovigilance compliance Manager / Auditor to join their PV and Epidemiology team for a 12-month contract. Specific Responsibilities Manage and lead routine and complex PV audits including internal processes, vendor and affiliate auditsWrite audit execution plansWriting audit reportsCommunicating audit findingsConduct risk assessmentsReview responses to audit reports to determine acceptability of proposed CAPAsPerform CAPA verification through review of objective evidenceEvaluate internal and vendor reported non-compliance and approve CAPA plansWrite CAPA effectiveness methodologyPerform CAPA effectiveness checksUndertake reviews of internal Procedural DocumentsTo be considered for the role of Pharmacovigilance Compliance Manager/ Auditor you will possess Pharmacovigilance and Auditing experience. Including an in-depth knowledge of global pharmacovigilance requirements and experience of TrackWise.Ability to travel (nationally and internationally) to conduct on-site audits (minimum of one audit trip abroad each month) Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on Required skills
Keyskills :
Audit CAPA Pharmaceutical Pharmacovigilance Quality Assurance Contract Audits Cambridge Uxbridge Compliance QA