Prompt reporting of adverse drug reaction information
Pharmacovigilance is an extremely important business that provides effective and safe treatments for patients by managing drug safety information. As one of the areas outsourced by major pharmaceutical companies, ClinChoice is actively involved in pharmacovigilance, providing high quality services to our clients with a focus on timelines, quality, and compliance.
ClinChoice already provides highly specialized services for a variety of tasks, including the collection of safety information on drugs and medical devices (reporting side effects in clinical trials and post-marketing, collecting information from literature and academic associations), analysis and evaluation of the information and responses based on the results (such as reporting to regulatory authorities), and implementation of safety assurance measures. Due to the worldwide exchange of safety information, ClinChoice maintains a flexible response system to meet the various requirements of our clients by securing personnel with high English proficiency and a rich work experience in order to maintain quality.
Currently, for a major foreign pharmaceutical company’s internal integration work, ClinChoice provides the following services
- Organization of post-marketing safety information data
- Analysis of post-marketing information data
- Medical evaluation of post-marketing safety information data
- Routine signal analysis
The work is highly challenging, aiming for clear milestones while utilizing cross-functional management skills and English communication skills, and building strong client relationships is highly valued.
PV Project Process for Clinical Trials
As part of the trilateral agreement in the ICH, the “Drug Safety Update Report (DSUR)” was established as a common standard for the periodic reporting of safety information on drugs under development, and unified global safety reporting is becoming a reality.
ClinChoice has over 280 PV specialists globally, processing over 2000 cases per month.