No! Of course, the entire process is much easier if all involved parties literally speak and use the same language. However, it is also possible to conduct studies in local language (with sites feeling comfortable with the system, understanding queries, and thus, providing solid data), while pharmacovigilance (and other time-sensitive tasks) are not in jeopardy. It just takes more efforts in terms of planning of the respective workflows and getting local and global processes in line.
For instance, delegate the translation, processing and query management around adverse event (AE) reports or pharmacovigilance related screening activities to personnel or organization units who are proficient in the respective language – this may be within or outside the MAH organization. Accordingly, consider the capacity of internal and external resources in this process a priori, preferably in the course of internal budget planning.
There may be steps that can be handled by local monitors, while others still require personnel commitment within the local or global organization (or respective outsourcing). For instance, a big international non-interventional study may be easy to handle for the pharmacovigilance departments of big country affiliates, but might be rather challenging for smaller country organizations.
Therefore, identifying the needs of all involved countries and defining the respective workflows is the main determinant whether you can offer your sites the benefit of a local language eCRF within your individual project.