Supporting the creation of PMS/PV related documents created by pharmaceutical companies and related tasks: creation support for post-marketing study implementation plans (draft), implementation guidelines (draft), periodic safety reports (draft), investigation results reports (draft), re-examination application materials (draft), PBRER, DSUR, and periodic reports of unknown non-serious adverse effects (draft), etc. Anyone who can respond to any of the above can apply. Company Info: Management of compounds, reagents, and solutions; CMC support; support for study planning, protocol creation; case registration, drug allocation, progress management; CRA/DM統解解析/safety information response work; support for development of regenerative medicine products; audit work; support for regulatory application work; international development, import/export support work, etc. Number of employees: 3,271. Requirements: Mandatory: Experience of 3 years or more in the creation and revision of periodic safety reports, re-examination application materials, etc. Optional: Experience in post-marketing study work or PV-related work in pharmaceutical companies or CROs; experience in English writing; experience in medical writing for clinical trials and research (experience in protocol and CSR creation); a background in medicine or pharmacy. Attractive points: It is possible to challenge documents that you have no experience in creating based on each person's willingness. Many writing tasks can be handled via remote work. With the approval of the supervisor, it is possible to schedule work according to individual circumstances, whether to commute or work from home.
The above information is a public job ad. This job ad is neither an offer nor a contract.
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