- an amazing opportunity to use your skills and experience
- a quality orientated organisation in the pharmaceutical industry
- working in an international environment
- a temporary contract or an independent contract from Derks & Derks Secondment & Interim
- a contract for 6 months with the possibility to extend
The organisation is an international pharmaceutical organisation that is operational in at least 40 countries across Europe, the Middle East and Africa. The operate on a global level and most of the teams have a global focus. They have everything in house like research, development, manufacturing, warehousing, but also sales and marketing. It is their hope to change tomorrow and to improve the lives of individuals like men, women and children, 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 ICSR Management Interface Associate at their office in Leiden.
As an ICSR Management Interface Associate you become responsible for interaction with other functions within and outside of PV Process to prepare and maintain supporting documentation for license partner-related activity, e.g. SAE reporting plans and reconciliation plans. You will keep abreast of relevant procedures to maintain knowledge of case processing activities and support in answering license partner requests. You will also be responsible for the Product Quality Complaint Management. Therefore, you will manage a central mailbox for non-ICSR related issues and to improve liaison with external and internal partners, particularly regional DSOs. Furthermore, you will represent Regional PV Process in inspections, PV audits and non-PV audits (GCP) as requested. You have a role in the Vendor & Outsourcing Management by regionally implementing and maintaining Business Partner/SDEA specific PV Process requirements. You will be responsible for completeness of exchange of Individual Case Safety Reports with license or co-developmental partners. Also, you will mutually establish business interactions allowing continuous improvement of reporting compliance. You will liaise with Affiliate Management, responsible for close alignment of regional affiliate activities. You cooperate with Business Partner Management for SDEA contents and you contribute to, or complete projects independently as directed. You will guide the completion of major programs and may have a project leadership role.
- Minimum BA/BS in Life Sciences.
- At least 1 year of relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical Development.
- In-depth knowledge and understanding of PV Process regulatory requirements and guidelines would be considered as an advantage.
- In-depth understanding of PV, data management and adverse event reporting and processing would be considered as an advantage.
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-1010-DD, to Sandra van Putten: firstname.lastname@example.org. 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.