AX-7185 Pharmacovigilance Audit Manager
Opportunity for a PV Auditor to join a global pharmaceutical company as their PV Audit Manager. You’ll provide QA leadership and oversight for PV and pharmacovigilance audit activities, including the establishment and maintenance of a risk-based audit strategy; oversight of contracted audits; and reporting on the PV and device vigilance risks, trends and effectiveness of the PV systems. This position is offered on a permanent basis, office based to the West of London and includes national and international travel.
Global Pharmaceutical Company
Global Headquarters / Global Remit
Travel involved to audit partner organisations
Reporting to Associate Director PV & QA
Responsibilities of the PV Audit Manager include: delivering the global risk based audit program to ensure effective QA oversight of PV activities, internally and externally. Overseeing and providing feedback to PV auditors to discuss findings, emerging risks and identify actions to address identified risks, ensuring formal feedback is provided to senior management on a regular basis.
You’ll also identify applications of PV QA regulations guidance and laws to existing methodologies to complex problems. Interpret PV impacting issues and recommend solutions/ best practices to continual compliance with policies and procedures.
Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements. Participate in and support PV client audits, PV Regulatory inspections and device vigilance aspects of notified body audits.
Plan and conduct PV audits of affiliates, partners and systems in line with the PV audit strategy.
You’ll also serve as Our Client’s PV QA expert within the business, proving advice and guidance to the organisation, third parties and partners.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Extensive experience within PV QA is essential, coupled with a scientific degree. .
Proven experience in over-sight of Pharmacovigilance QA activities for commercial marketed products
Experience supporting partner audits and competent authority PV inspections
Strong analytical skills with highly developed quality system knowledge
Excellent influencing skills and ability to establish effective working relationships with personnel at all levels internally and within third parties
Proven experience in auditing a wide range of GVP processes and suppliers
Medical Device Vigilance experience is desirable
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.
Bonus, Pension, Private Medical, Car Allowance, Life Assurance
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market.