PV Auditor

Company Description

Introduction 

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.  

Job Description

This role effectively manages and conducts internal and external (third-party) audits to provide independent and objective fact-based opinions and to assure compliance with applicable Primevigilance and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements.

Role and Responsibilities

Principal Responsibilities:

• Conduct audits initiated by PrimeVigilance, according to the agreed Audit Plan including effective management of pre-audit activities.
• Audit types include:
  Audits of PrimeVigilance’s Partners and Vendors/Service Providers
  Internal Audits of Projects and Processes
• Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
• Principal Functions and Responsibilities may include but not inclusive of the following: Co-Auditor for full Vendor and Internal System Audits, Lead for Full PV Vendor Audits

Qualifications

• B.Sc. in Science, Nursing, or related scientific field.
• Sufficient experience in pharmaceutical and/or biotech pharmacovigilance, with an good understanding of GVP-related Quality Management and Assurance, and adequate GxP auditing experience in an Audit Lead role.
• GxP Knowledge: In-depth knowledge of the applicable GxP regulations eg EU and FDA regulations particularly EU GVP
• Analytical, written and oral communication skills.
• Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving
• Strong team player
• Good / Strong English language skills (written and spoken) additional languages a plus, but not required
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Other EDMS e.g. Veeva Vault, Master Control, Trackwise a plus, but not required

Additional Information

Why PrimeVigilance 

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally  
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

• Quality 
• Integrity & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look forward to welcoming your application.