Pharmacovigilance QA Manager

Join our clients company as a Pharmacovigilance QA Manager, and work as a auditor and a advisor to the organization.

• 7 years of experience in clinical/Pharmacovigilance QA, or in the pharmacovigilance function
• Excellent knowledge of QA Standards, particularly Good Clinical and/or GPvP Practice Guidelines and Regulations and other related areas specific for the function (e.g. PV), as well as basic legal regulations
• Minimum bachelor’s degree
• Fluent English
• Quality assurance/auditing certification or credentials through recognized quality standards organization is preferred
• Very good interpersonal and communication skills
• Ability to influence without authority
• Project management skills
• Excellent attention to details
• Flexibility and adaptability
• Current location in Poland

• Execution of regional, cross regional and/or global multiple audit programs
• Provide unsupervised GPvP expert advice to key personnel, including coaching on QA related processes, interpreting health authorities’ requirements and advising in their implementation across the organization
• Support the development, improvement and maintenance of the Company's Quality System by signalling root causes to non-conformances related to the system and addressing observed gaps
• Manage Quality Issues related to critical non-conformities, serious misconduct and potential fraud
• Lead corrective and preventive actions identification and roll out and ensure follow up with effectiveness measures
• Develop, analyze and report relevant key performance indicator information
• Develop and manage interfaces with QA departments of service providers to ensure QA oversight and risk mitigation

Employment agency entry number 47

This job offer is intended for people over 18 years of age

Current location in Poland required