Experienced staff will assist you in evaluating and analyzing safety information generated in clinical trials, post-marketing surveillance, literature and academic society survey on pharmaceuticals, medical devices and reporting to PMDA.
|・Primary evaluation of foreign information by CIOMS/MedWatch forms and Japanese translation|
|・Primary evaluation of safety information in clinical trials, post-marketing in Japan and English translation|
|・Translation of Safety report from overseas headquarters and preparation of reports to regulatory authority.|
|・First evaluation of overseas literature academic society information and Japanese translation.|
|・Preparation of Reports on Adverse Drug Reactions and Infectious Diseases, etc. to PMDA and Research, Measurement and defect reports(draft).|
|・Secretariat Duties of Evaluation of Efficacy and Safety Committee|
|・Consulting general safety information management tasks and other related works in general|
Please consult about other business.
|・Major pharmaceutical manufacturer|
|・Major global medical device manufacturer|
|・Major Japanese medical device manufacturer|
CXMJ Safety Information Management
- Multiple staff who conducted Pharmacovigilance practical experience at major global pharmaceutical manufacturers for more than 10 years will support fully.
- Specialty fields are Medical Devices(biological valves and cardiovascular devices), Cancer(solid tumor, blood cancer), Immunology, Allergy, Metabolism(lipid, sugar), Cardiovascular, Hormones, and Orphan drugs.
- The person in charge has abundant medical knowledge and English ability.
- We will respnd firmly to your request and the same staff will be responsible for actual work from planning to the completion.
- To raise the quality, QC personnel also have experienced Pharmacovigilance.
Finally, personality is important. We value the relationship of trust with the person in charge of your company.