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Job Location | Camden (London Borough) |
Education | Not Mentioned |
Salary | Competitive salary |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
(Senior) Pharmacovigilance Auditor for a global pharmaceutical company A well-established, exciting and global pharmaceutical company are now searching for an Auditor or Senior PV Auditor to join their close-knit team to be based remotely either in the UK or EU. They are market leaders in Semi-Synthetic Penicillins and as wellas this, they have a presence in exciting therapeutic areas such as neuroscience, cardiovascular, anti-retrovirals, gastroenterology and many more.This is an exciting long-term prospect as the company keeps growing, providing excellent exposure on a global scale in a collaborative, diverse and like-minded environment. You will be provided with plenty of support and they company are renowned for theirdiversity, scale, leadership, patient focus and operational excellence. As well as this they have sustainability at their forefront and have put in clear efforts to benefit the communities they work with.This an opportunity provides great variety, and you will be reporting directly into the Head of EU PV. You will manage and support the tracking the EU PV audit schedule (including findings of CAPAs) and audits will generally be for main global PV departmentsand affiliate local PV systems. Your main responsibilities will include, but are not limited to:- Management of PVQA audits and inspections and conducting audits as lead PV auditor - With a main focus on key EU markets, the management of process audits and affiliates audits - Support for relevant rest of the world PV audits - CAPA and deviation management (including quality control and effectiveness) - Compliance reporting and ensuring companys PV activities are completed in line with requirements/legislation - Mentoring junior auditors and PVQA professionals - Training staff for inspection readiness and supporting PV inspections- Supporting PV project management - Working relationships both internally and externally What do you need - A life sciences degree- A strong background in pharmacovigilance (5 years+ as well as 2 years+ experience in GVP auditing) - Willingness to travel between 25-40% - Excellent understanding around EU and local PV regulations- Ideally experience in generic pharmaceuticals- Excellent communication skills- Proven ability to working independently, prioritise tasks and influencing others to achieve resultsIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now. If this job isnt quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Keyskills :
directorsafetyquality assuranceofficerspecialistpharmaceuticalscroscientistsurveillancepharmadrug safetypharmacovigilanceassociate directorassociateaggregate reportsmedical safety