Senior QA Auditor job in

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Position Summary:

Perform GVP audits of pharmacovigilance process and systems in order to assure compliance with ICON or Sponsor SOPs, Good Pharmacovigilance Practice guidelines and relevant regulations.
Assist with the implementation and maintenance of an effective Pharmacovigilance Quality Assurance program within ICON.
Assist with the professional development of QA Auditors.

Senior PVQA Auditor Role at ICON:

Effectively Plan and conduct PVQA audits in order to assure that safety related activities managed by ICON are of the highest standard and are in compliance with the requirements of ICON/Sponsor Standard Operating Procedures and relevant regulations.
Maintain a thorough knowledge of all relevant ICON SOPs, Good Pharmacovigilance Practice guidelines and relevant regulations.
Perform quality system audits and process audits.
Perform supplier/vendor audits.
Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
Assist with the review of audit reports and audit results, and with performing analyses and trending of audit results, as required.
Assist with the planning and coordination of specific projects related to the development and Improvement of the ICON Quality Assurance program
Perform lead auditor duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results.
Perform QA Review of SOPs, as required.
Train and mentor new QA auditors in order for them to perform their function effectively and provide a benchmark of auditing competencies to less experienced colleagues.
Liaise with clients and project managers on quality aspects of safety related activities including attendance at meetings, oral presentations and audits.
Assist with business development activities, as required.
Coordinate or assist with Sponsor audits and Regulatory Inspections, as required.
Assist with the management of the department when requested including resourcing, assignment of workload, and scheduling and review of audits.

To succeed you will need:

University/Bachelors Degree or local equivalent in medicine, science or equivalent degree/experience.
In depth proven experience in a quality/regulatory pharmacovigilance compliance position.
Thorough experience in pharmacovigilance auditing.
Comprehensive knowledge of GVP and GCP requirements and experience with global regulations and guidelines including post-marketing pharmacovigilance.
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams and clients.
Ability to make and defend pragmatic quality decisions relating to pharmacovigilance activities.
Good commercial awareness and customer focus.
Detailed understanding of drug development, clinical trial and drug safety processes.
Demonstrated training skills, including the ability to give constructive feedback.
Highly developed problem resolution skills.
Good planning and organizational skills with the ability to multi-task and prioritize effectively.
Ability to work efficiently and independently under pressure.
Cost consciousness.
Ability and willingness to travel at least 35% of the time (international and domestic)

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

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Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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Senior QA Auditor

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