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European Qualified Person for Pharmacovigilance (EU-QPPV)

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Deel deze vacature

Our client is a global pharmaceutical company focused on developing and commercialising innovative therapies for the treatment of rare diseases. With a strong focus on recombinant protein therapies, they utilise cutting-edge technologies to create life-changing medicines. Known for their commitment to scientific advancement, this company is focused on addressing critical, unmet medical needs and improving the quality of life for patients facing rare health challenges. In their constant evolution, they are looking for a European Qualified Person for Pharmacovigilance to join their team. If you’re passionate about making a difference and working with some of the brightest minds in the industry, this is the place to be.

Details

Pharmaceutical

Pharmacovigilance

Leiden - Netherlands

40 uur per week

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Zo maak jij het verschil

As a European Qualified Person for Pharmacovigilance you will play a critical role in ensuring the safety and efficacy of medicinal products within the European Economic Area (EEA). You will establish and maintain the pharmacovigilance system, act as a point of contact for the  European Medicines Agency (EMA) or National Competent Authorities (NCAs) in the EEA. Moreover, you will ensure that the Deputy QPPV, and any other supporting role, is suitably trained and informed. You will also contribute to SMT/Safety Committee meetings as a quorum member.

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Wat jij mee brengt

You, as the ideal European Qualified Person for Pharmacovigilance will recognise yourself in the following :  - Degree in medicine or postgraduate qualification in a medical science, profiles from other education backgrounds will be considered if they have extensive experience of quality management in PV - Minimum 5 years of experience in pharmacovigilance for Medicinal products under development and marketed MPs - Previous experience in QPPV role or Deputy QPPV - Understanding of the EU legislation and Guidelines on Good Pharmacovigilance Practices (GVP) Modules - Knowledge of International standards for PV

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Jouw voordelen

What we offer: - Competitive salary and benefits package - Impactful work: contributing to the development of life-changing therapies for rare diseases, improving patient outcomes - Learning opportunities: exposure to cutting-edge biotechnological research, hands-on experience - 30 vacation days

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