- 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 Secondment & Interim
- a contract for 12 months with the possibility to extent
As a ICSR Management Liaison Manager you will be responsible to ensure PV requirements are incorporated in protocol design for interventional as well as non-interventional studies and Market Research Programs and/or Safety Management Plans for clinical studies or organized data collection programs conducted in (assigned) region. You will build and maintain close relationships with DSOs, Regulatory Affairs, Clinical and Medical Affairs functions in the assigned region. Also you will be responsible for the product quality complaint management for operational execution of Product Quality Complaint processing and evaluation in the assigned region (triage, forwarding, investigation, reconciliation and reporting). You will representing Regional PV Process in inspections, PV audits and non-PV audits (GCP) as requested. But also you will oversee regulatory compliance and QC of outsourced activities and implement business regulatory compliance and inspection readiness requirements in cooperation with regional PV Process assigned license partners. In this role you will report to the manager of the department and working with you coworkers around the world.
- minimum BA/BS in Life Sciences
- minimum of 5 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical development
- in-depth 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
- in-depth knowledge and understanding of PV Process regulatory requirements and guidelines in the assigned region
- proven experience with (GxP) Qualities Management System.
- in-depth understanding of PV, data management and adverse event reporting and processing.
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 Liaison Manager at their office in Leiden.
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-078-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.