Informacje o stanowisku

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

What we expect

• 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 as specific for the function (e.g. PV), as well as basic legal regulations
• min. 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

Employment agency entry number 47

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

What we offer

• emloyment on b2b / contract of employment via Randstad for 12 months with the chance for longer cooperation
• working for a fact growing company from pharmaceutical sector

Your tasks

• execution of regional, cross regional and/or global multiple audit programs
• provide unsupervised GPvP expert advice to key personnel. This includes and is not limited to: 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 Companys Quality System by signalling root causes to non-conformances related to the system, by addressing observed gaps in the system
• manage Quality Issues related to critical non-conformities, serious misconduct and potential fraud. Lead proper 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 of the service provider and that any risk to the companys business is being mitigated

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