Senior QA Auditor job in

This vacancy has now expired. Please see similar roles below...

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.

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Reasonable Accomodations

List #1

Day in the life

Shining a Light on Endometriosis Awareness Month

Teaser label

Inside ICON

Content type

Blogs

Publish date

04/18/2024

Summary

Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis

Teaser label

Endometriosis Awareness Month sheds light on this often-misunderstood condition affecting millions worldwide.

The Role of Data Management in Clinical Trials

Teaser label

Industry

Content type

Blogs

Publish date

04/18/2024

Summary

Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials

Teaser label

This blog examines the critical role of data management in clinical trials.

Navigating the Clinical Research Supply Chain

Teaser label

Industry

Content type

Blogs

Publish date

04/12/2024

Summary

Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ

Teaser label

Discover the intricate workings of the clinical research supply chain in this comprehensive guide.

View all

Similar jobs at ICON

Clinical Study Administrator

Salary

Location

Taiwan

Department

Clinical Monitoring

Location

Taiwan

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Clinical Study Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Clinical Study Associate Taiwan Office bas

Reference

2024-110053

Expiry date

01/01/0001

Read more Shortlist Save this role

Manager, Drug Safety

Salary

Location

Japan

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Japan

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ

Reference

2024-109906

Expiry date

01/01/0001

Author

Daiki Matsumoto

Author

Daiki Matsumoto

Read more Shortlist Save this role

Site Support Manager, Patient Recruitment

Salary

Location

UK, Reading

Location

Sofia

Prague

Budapest

Dublin

Warsaw

Lisbon

Bucharest

Johannesburg

Barcelona

Madrid

Edinburgh

Reading

Warwickshire

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Patient Recruitment

Job Type

Permanent

Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It

Reference

JR117762

Expiry date

01/01/0001

Author

Hajni Howard

Author

Hajni Howard

Read more Shortlist Save this role

CRA II

Salary

Location

Colombia

Department

Clinical Monitoring

Location

Colombia

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us

Reference

2024-109736

Expiry date

01/01/0001

Author

Magda Obregon

Author

Magda Obregon

Read more Shortlist Save this role

Clinical Research Coordinator Nurse

Salary

Location

US, Winston-Salem, NC 27103

Location

Winston-Salem

Business Area

ICON Full Service & Corporate Support

Job Categories

Nursing

Job Type

Contractor

Description

Reference

JR118118

Expiry date

01/01/0001

Author

Mitzi Overton

Author

Mitzi Overton

Read more Shortlist Save this role

Senior Clinical Research Coordinator

Salary

Location

US, Winston-Salem, NC 27103

Location

Winston-Salem

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research In-Home Services

Clinic

Job Type

Permanent

Description

Reference

JR117595

Expiry date

01/01/0001

Author

Mitzi Overton

Author

Mitzi Overton

Read more Shortlist Save this role

Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

Overview of Service Lines

Why icon? full service mean for you?

graduate What does full service mean for you?

Senior QA Auditor

About the role

This vacancy has now expired. Please see similar roles below...

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

Application process

Who we are