- An amazing opportunity to use your skills and experience by helping out this client.
- A quality-orientated organisation in the pharmaceutical industry.
- Working in an international environment.
- A temporary contract or an independent contract from Derks & Derks.
- A contract for six months with the possibility to extent.
The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the middle east and Africa. They operate on a global level and most of the teams have a global focus. They do Research, Development, Manufacturing, Warehousing but also Sales and Marketing. It is their hope to change tomorrow’s world and to improve the lives of by providing innovative medicines in areas of health where there is urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. Wouldn`t it be lovely to join them in their journey? At this moment they are open to meet an enthusiastic candidate for a temporary position as Associate QPPV Officer at their office in Leiden.
As an Associate QPPV Officer you 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). Therefore you need to ensure that the document Management system used for the storage and archive of the PSMF contains the most up-to-date version for each section or annex, as provided by the PSMF stakeholders to ensure publication and submission of the PSMF within agreed timeliness. Furthermore, you will collaborate 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. You are going to be 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 PSMF. In this role you work with an international team on a global level you will report to the Associate Director QPPV-Office. As a team you will contribute to the development, implementation and successful execution of the GPV mission, objectives and strategic plan.
- Minimum Bachelor’s degree with two years’ experience in pharmaceutical, biotechnology, or a related industry.
- Minimum of one year of significant experience in Pharmacovigilance, Regulatory affairs or Safety Quality Assurance, including establishing standards in support of the safety quality systems.
- 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 and 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, and ability to interact with all levels of personnel.
- Must be able to communicate in English.
- Able to work with computers (including Microsoft Office, Access, and Project)
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-096-DD, to Sandra van Putten: email@example.com. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.