Associate QPPV OfficeA new opportunity has arisen with a market-leading pharmaceutical company working as an Associate QPPV Officer. Our client is seeking an experienced and dynamic individual to take on this role, which will work from their head office in Leiden.
FunctieomschrijvingThe successful candidate will be responsible for
- Performing operational activities, implementing and maintaining operational plans and tools to support the QPPV Office for the maintenance of the pharmacovigilance System Master File (PSMF).
- Collaborating with the QPPV Office team for the development of procedures and projects to ensure compliance with all applicable global requirements for the PSMF and EU-QPPV oversight.
- Collaborating with relevant GPV and non-GPV partners (e.g., Global Clinical and Research Quality Assurance, Glob al Regulatory Affairs) for the maintenance of the Pharmacovigilance System Master File (PSMF).
- Reports to the the Associate Director QPPV-Office . Is a member of the QPPV Office team and contributes to the development, implementation and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
- Minimum BA/BS;
- Minimum of 2 years in pharmaceutical, biotechnology, or related industry;
- Minimum 1 year significant experience in Pharmacovigilance, Regulatory affairs or Safety Quality Assurance, including establishing standards in support of the safety quality systems, especially as they impact and influence multiple departments and levels of management;
- Understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations, experience and understanding of Process Management,
- Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle;
- Understanding of PV and Clinical Research processes, and other processes making up the PV system, including the interfaces between these processes;
- Good understanding of PV, data management and adverse event reporting and processing;
- Excellent oral and written communication skills, ability to interact with all levels of personnel;
- Must be able to communicate in English (active and passive), other languages considered an asset;
- The preferred location for this position is Leiden, Netherlands.
BedrijfsinformatieOur client is an international pharmaceutical company with more than 15,000 employees worldwide. The company has an extremely solid reputation as a research-oriented company and a leading position within the pharmaceutical industry.