Regulatory Affairs
-Drug product registration/ product variation applications.
-Follow up amendments related to MA license variation
-Monitor routinely pharmaceutical regulation and policy changes and assess impact for timely implementation and notice of other stakeholders.
-Maintain/manage registration files and RA database in shared drive of RA.
-Submission of drug reimbursement application to HIRA or MoWH.
-Support drug reimbursement project.
Pharmacovigilance
-Handling of drug safety related information and report it to HQ and local authority
-Report monthly reconciliation with MIS & Quality complaints
-Provide PV training to relevant stakeholders
-Fulfill the required tasks according to local & global procedure and regulations.
-Management of local PV SOPs
경력 및 자격요건
-Qualification of pharmacist in bachelor or higher degree.
-3 ~ 5 years’ experience in RA and/or PV in pharmaceutical company
-Proficient in MS Office, including Word, Excel and PowerPoint
-Good verbal and writing English skill is preferred
-Knowledge of pharmaceutical regulations
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
