株式会社CXメディカルジャパン

お電話でのお問い合わせ 03-5298-5313 受付時間 平日 9:00~17:30
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Pharmacovigilance

Experienced professional staff will support you on pharmacovigilance work promptly and accurately.29d198683284284537bc27241351d4a5_s

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.

 Service

 ・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.

Achievement(Dealings manufacturer)

・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.

お電話でのお問い合わせ 03-5298-5313 受付時間 平日 9:00~17:30