Providing Speedy and Reliable Pharmacovigilance Service through our Well-established team of Highly-skilled Professionals
Our highly professional staff with extensive experience in GVP provide consultation as well as proposals that best meet the needs of our clients. Our approach ranges from registration, data entry, and QC to translation and preparation of evaluation drafts. We can respond flexibly to our clients’ requests and are available both on-site at the client’s office and through our data center.
- Point 1.
- Well-organized and well-prepared team of professionals in pharmacovigilance and MD to meet your needs.
- Point 2.
- Proven and trusted brand to implement all projects from registration to evaluation draft preparation tailor-made to your requirements.
- Point 3.
- Ability to provide extensive and comprehensive support of pharmacovigilance from consultation and IT system assistance.
Services Provided for GVP
Domestic Safety Information Requirements
- Preparation of primary evaluation drafts, Planning reexamination item drafts, and Case entry into database
- Provision of quality check of evaluation content and data entry
- Preparation of CIOMS
- Design of reexamination items, Requests for reexamination and Support for MRs and CRAs
- Preparation of individual case report drafts to PMDA concerning AEs, Infections, and medical devices defects
* The above services are provided by INTAGE Healthcare staff on-site at the client office.
Foreign Safety Information Requirements
- Preparation of primary evaluation drafts on foreign information by CIOMS and Med Watch
- Preparation of individual case report drafts for submission to PMDA on AEs, Infection, medical devices defects
- Consultation on Pharmacovigilance
- In-country Clinical Caretakers
Message from Pharmacovigilance Staff
My experience with CIOMS in a previous job was an opportunity to acquire in-depth knowledge of and experience in pharmacovigilance including collection, evaluation and safety information that I now put to good use at INTAGE Healthcare. This job requires me to have not only knowledge of drugs and diseases but also domestic and international regulations, which were a real challenge for me. The various internal and external training opportunities provided by the company as well as support from team members were a huge help for me.
I started my career in pharmacovigilance at a client’s office handling their communication with overseas offices and their compliance issues. Currently, I am responsible for safety evaluation.
Our department consists of an experienced staff who all have extensive consultation experience as well as firsthand knowledge from safety evaluation experience over the years. I believe this is one of our strengths and I am proud to be a member of the team. We gain new knowledge on a daily basis and strongly feel our contribution to a better society.
H.K. has 20 years of experience in Pharmacovigilance
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