The importance of incorporating patient-reported outcomes (PRO) assessment into the practice of medicine is well recognized. Measurement of PRO in real-world clinical practice, however, is not commonly performed because of limited time spent with patients due to the busy schedules of clinicians, whose primary focus is to achieve a symptomatic cure. A post marketing safety surveillance (PMS) is one of a few opportunities to obtain non-interventional, prospective, real-world data about PRO, since PMS is a must due to regulatory requirements in many countries. Indeed, cross-continent planning and collaboration will be required to understand similarities and differences as PMS studies become a standard practice for multi-national research. Whereas PRO results are useful to evaluate patient-relevant effectiveness of the drug, the implementation of a PRO survey in PMS in different countries requires careful preparation, such as: facilitate multidisciplinary team communications for proper design of a PRO survey and selection of a validated survey questionnaire for all participating countries; strategize the recruitment of clinicians and patients; develop training materials for patient recruitment; handle adverse-event-like symptom questions in a questionnaire for adverse drug reaction reporting; develop the report format of PRO survey results to regulatory authorities; and develop a communication plan of PRO assessment results to stakeholders, such as physicians and patient organizations.  We will discuss above issues associated with a PRO survey as a part of PMS from both Pharmacovigilance and Outcomes Research points of view based on our experience in Japan. A comparison will also be made about study planning with a PRO component between Japan and global PMS (such as the Post-Authorization Surveillance required by the European Medicines Agency), to highlight important lessons and implications for PRO researchers and practitioners to enhance the usage of PMS as a valuable opportunity to obtain real-world PRO assessments.