Pharmacovigilance Director (EU QPPV)
- Farmaceutische Industrie, Manufacturing, Market Access
- Vast (1,0 fte)
As the Pharmacovigilance Director, for the European Union, (Inc. United Kingdom) you will be responsible for providing the legal framework for pharmacovigilance of medicinal products. In addition you will be responsible for establishing, maintaining, and managing the Marketing Authorisation Holder’s pharmacovigilance system, to ensure that the system has a clear overview of the safety profiles and any emerging safety concerns in relation to the medicinal products.
You will be reporting to the Vice President of Global Pharmacovigilance and Risk Management.
Inhoud van de functie
- Active involvement in risk management and evaluation activities through either attendance at or receipt of agendas and minutes for Safety Review Committee meetings;
- Review and approval of regulatory communications, analyses, or reports for product(s)
- Review and sign off on regulatory action in response to emerging safety concerns such as those that result in labelling changes in the EU and the UK
- Involvement in preparation of applicable contractual arrangements with external service providers, distributors, and business partners.
- Awareness of activities associated with the validated safety database, including significant changes associated with the database
- Participates in assessment of global pharmacovigilance system issues to facilitate growth and harmonization of processes across all regions that involve both marketed products as well as products in clinical development.
- Medical physician (M.D. or equivalent) with a minimum of seven (7) years’ experience in the pharmaceutical/biotechnology industry in pharmacovigilance/drug safety
- Excellent understanding of drug development and life-cycle management of medicinal products
- Knowledge of pre-and post-marketing US, EMA, and worldwide safety regulations
- Experience in developing and executing risk management strategies
- Fluent in written and spoken English
- Ability to travel as needed
- Must be located in the Netherlands or willing to relocate
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