As an experienced (Senior) pharmacovigilance auditor you will be responsible for managing and executing the Xendo pharmacovigilance (PV) audit programme you will be conducting audits across the entire range of PV relevant activities, with primary responsibility for planning and participating in global PV audits. The breadth of audits performed include the end to end PV system including PV system key elements, PV QMS , service providers, internal and affiliate audits on behalf of Xendo clients.
Xendo is a consultancy and project management organisation in the (bio) pharmaceutical, medical devices and healthcare fields. Our clients are predominantly operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo delivers a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Our Pharmacovigilance Division that is a legacy of the Vigilex Company became part of Xendo in 2015 The work in this division is performed on a national, EU and Worldwide level.
Audit team within the Pharmacovigilance Division, reporting to the Managing Consultant of the team.
Who we are looking for:
Those who dare to make the difference – in the way they act, collaborate, advise and lead. We are looking for a highly motivated and experienced professional who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your clients and the ability to adjust to these needs and function as a partner and advisor to the client is essential. You need to have a pharmacovigilance, medical or paramedical background or a degree in life sciences in combination with a solid knowledge of international pharmacovigilance regulations and guidelines. At least 5-10 years of experience in various roles within pharmacovigilance area or within the pharmaceutical industry with safety related roles, government agency or a PV consultancy organization is an absolute requirement. Audit experience is required and QPPV experience is preferred.
Being a Xendo Auditor you will have the opportunity to work in a wide variety of projects for different companies. This position as (senior) consultant is for the auditors team of the Pharmacovigilance division. Your audit activities will cover the entire range of PV processes, including from inspection support of our clients, Mock Inspections/ HQ audits, local affiliates/partners/vendors or tailored to a specific PV process. For our various longstanding clients, audit project management and maintenance of a good client relationship will also be an important part of your work. Training clients’ staff on PV regulations or assist in inspection preparations may also be part of your role. Our team is multinational, with several team members working home-based full time.
You may also be assigned as (deputy) QPPV to one or more clients. This concerns mainly smaller and medium-size companies, who often have a PV system under development or are undergoing major changes with (initial) marketing authorization applications. Your input as PV expert is key to these clients, but in addition we also consider (deputy) QPPV work experience a great asset to our auditors’ qualifications as they are through this role involved in all pharmacovigilance relevant processes and procedures of the client.
- Medical or paramedical background or degree in life sciences;
- Solid knowledge of international pharmacovigilance regulations and guidelines;
- At least 5-10 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organisation;
- Audit experience is a must;
- Good communication and interpersonal skills;
- Able to quickly adapt to different working environments and the different cultural aspects of our clients;
- Client-oriented, dedicated, flexible, able to manage timelines and prioritize your work;
- Excellent knowledge of and experience with pertaining international legislation, guidelines and directives and able to assess the impact of changes in your areas of expertise
- Proficient in English language, both in speaking and in writing. Good command of a second language is an advantage.
Please contact Helena van den Dungen, Director Pharmacovigilance at +31 71 524 40 00 or by e-mail for additional information on job specifics.
- a dynamic and varied position in a fast-growing and professional company;
- good terms of employment;
- focus on continuously extending knowledge and experience;
- great projects in all aspects of GxP compliance and validation;````````````````````````
- projects at both small and large life science organisations and suppliers.
If you are interested in this position, we encourage you to send your motivation and CV to us.
Agency or sales calls are not appreciated