※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Salary] 9〜13 million JPY ※Experiences and skills will be considered
◆Safety management activities:
- Ensure that the safety management activities in Japan run smoothly and efficiently in compliance with Pharmacovigilance requirements in Japan under the direction of the director
- Perform/arrange for translation of Pharmacovigilance documents
- Harmonize PV process and practice in Company Japan with GPV in cooperation with the director
◆Adverse Drug Reaction case management:
- Perform ADR case follow up with doctors and other health care professionals in Japan
- Perform ADR case assessment/QC and Submit ADR case reports to PMDA, Japan
- Perform Literature screening
◆Periodic Safety Reports:
- Develop, review and submit aggregate reports and J-PSURs to PMDA, Japan as applicable.
◆Medical Information Management:
- Manage medical information requests.
◆Product Quality Complaints:
- Communicate any Product Quality Complaints received to quality assurance for investigation.
- Develop and review of Pharmacovigilance Agreements with business partners and service providers.
- Safety assurance activities for products laid down as part of condition marketing authorization in Japan
- Communicate with regulatory bodies in Japan on matters related to safety
- Support of audits/inspections in Japan and prepare corrective and preventive action reports.
- Maintain records of all safety assurance measures & reports in accordance with PMDA, Japan and applicable SOP requirements
- Conduct self-inspection
- Experience of working Pharmacovigilance over 7 years period
- Knowledge and faculties of pharmaceutical and medical science
- Team building for running appropriate activities
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance