우리회사의 자랑거리를 #태그로 표현해보세요 우리 회사에 대해 4줄 이내로 소개해주세요 [Novotech] Sr. Pharmacovigilance Associate 경력 정규직 채용 노보텍아시아코리아(주) 모집부문 및 자격요건 담당업무 자격요건 인원 [근무부서 및 직급/직책] • Support to set up the related system and safety database such as Oracle Argus Safety, ArisGlobal ARISg, Veeva VaultSafety, CRScube cubeSAFETY. • Support to set up and update the related SOPs and ensure the regulatory compliance. • Support the PV related work in the clinical projects including but not limited to case processing, review of annual safety report, expedite/periodic reporting of safety information to regulatory authorities/investigators/IRBs/sponsors, and the preparation of safety management plan. • Support to perform post-marketing PV service tasks including but not limited to case handling, literature searching and reviewing, expedited / periodic reporting of safety information to regulatory authorities/sponsors in compliance with regulatory timelines. • Support to prepare periodic aggregate reports (PSUR/PBRER/DSUR) and Risk Management Plan. [자격요건] • Bachelor of pharmacy/nursing/medicine/biology or a related major. A master/PhD degree is preferred. • 3 years of PV relevant experience is preferred. • Proficient knowledge of safety data base (such as Oracle Argus Safety, ArisGlobal ARISg, Veeva VaultSafety, CRScube cubeSAFETY) are preferred. • Fluent in both written and oral English 1 명 근무조건 고용형태: 정규직(수습기간6개월) 급여조건: 연봉 협의 후 결정 전형단계 및 제출서류 전형단계: 서류전형 >; 폰 스크리닝 >; 실무진 면접 >; 레퍼런스 체크 >; 최종합격 추가 제출서류 영문 이력서 (Word 또는 PDF 파일) 접수방법 접수방법: 자사 홈페이지 기타 유의사항 입사지원서 및 제출서류에 허위사실이 있을 경우 채용이 취소될 수 있습니다. 00
의료·보건·복지>약사·제약>의료기·의약품인허가|의료·보건·복지>약사·제약>제약연구개발
