Our client, a leading European pharmaceutical company is looking to recruit a
Quality Assurance Coordinator for Pharmacovigilance (m/f) for their Head Office in Luxembourg.
Major responsibilities: -
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Implement and maintain an effective Pharmacovigilance audit program (global audit methods, techniques and criteria for establishing metrics) for the Central Drug Safety Unit, Affiliates, Licensees, Licensors, etc.; Participate in the development of corporate PV audit policies, SOPs, working instructions & guidelines; Conduct/participate in audits as necessary and monitor corrective action plans; Analyze results of PV audits in conjunction with the EUQPPV and communicate issues and areas of risk to Senior and Executive Management; Assist auditees in developing and implementing effective resolution of compliance issues; Work closely with Drug Safety teams to ensure that PVQA audit plans are implemented; Develop relationships with key internal and external partners; Monitor current industry compliance trends, and modify audit programs accordingly; Analyze the results of PV audits, generate metrics and periodic reports and communicate issues/risks to Senior Management; Perform validated Pharmacovigilance training of company personnel in-line with corporate procedures and training plan; Manage the audit program of the Company’s Pharmacovigilance activities against company’s standards and applicable regulatory requirements; Perform Quality Control on reporting of audit observations and the associated risk ratings applied to those audit observations; Serve as a Pharmacovigilance compliance consultant; Track completion of agreed upon corrective actions as a result of Pharmacovigilance audits and Regulatory Inspection commitments; Identify opportunities for process improvement; plan, implement and evaluate changes in conjunction with corporate and department goals.
Technical requirements: -
University degree in a science related field or an equivalent previous experience in healthcare; An established Quality Assurance and Drug Safety experience in the pharmaceutical industry; Proven PV auditing experience or broad management responsibilities within a global Drug Safety department;