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.
Qualified candidates must have :
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 and / or QPPV experience is preferred
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.
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