Job Reference: J5632512
Updated On: 12/11/2019
Status: Open to Applications
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Role OverviewA fantastic opportunity for a Global Pharmacovigilance Audit Manager has become available within a Global Pharmaceutical company based in the Middlesex area. As the Global Pharmacovigilance Audit Manager you will be responsible for all Global PV audit activities including the development and execution of audit strategies.
This position with suit a Pharmacovigilance professional with Quality and Audit experience looking to expand their career and act as Lead on Global Audits both internally and externally.
Key Duties and ResponsibilitiesYour duties as the Global Pharmacovigilance Audit Manager will be varied however the key duties and responsibilities are as follows:
1. You will work closely and cross functionally with Senior Management teams and report to VPs and Directors across the business to ensure company compliance. You will assess and submit new audit strategy and play an integral role in the compliance of PV activities where you will have the ability to influence and challenge process improvements.
2. You will be accountable for conducting PV and DV audits in line with GVP Regulations. You will focus at a Global level and ensure gaps are identified through risk management strategy.
3. You plan and conduct PV audits of processes, affiliates and 3rd party providers and partners. You will manage remediation actions to ensure PV activities are brought to compliance.
4. Ensure continuous compliance of PV policies and procedures and ensure PV departments globally are inspection ready for audits by notified bodies.
Role RequirementsTo be successful in your application to this exciting opportunity as the Global Pharmacovigilance Audit Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific discipline (e.g. Pharmacology; Chemistry; Biology; Pharmacovigilance etc.) in addition to experience of working in a Pharmacovigilance setting within industry.
2. Proven industry experience of focusing on Quality Assurance aspects of Pharmacovigilance where you have exposure to audits and compliance processes.
3. An indepth knowledge of Good Pharmacovigilance Practice (GVP) is essential for this position as well as knowledge of Quality Management Systems (QMS) and improvement processes.
Key Words: Pharmacovigilance | PV | Quality Assurance | QA | Audits | Auditor | Compliance | Medical Device Vigilance | CAPA | CAPA Management | Risk Management | RMP | Quality Management Systems | QMS
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