모집부문 및 자격요건

•  Summary of Job Purpose
•  Manage and conduct PV activities for product life cycle
•  Conduct the activities for managing PV system and its quality system
•  Conduct the activities for maintaining domestic and global licensing rights
•  Communicate with Regulatory Authorities
  
  
• Roles and Responsibilities
•  Ensure the managing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
•  Approval of ICSR based on the results of quality/medical review
•  Manage expedited and regular reporting to regulatory authorities
•  Authoring and/or reviewing aggregate safety reports (DSUR, PSUR/PBRER), Risk Management Plans, report for Renewal Market Authorization
•  Supervise of risk/signal management process
•  Manage the literature search and approval the results
•  Supervise PV training (PV team, company-wide, refresh, advanced etc.)
•  Review and approval of training material, assessments, and courses
•  Develop, revise and review the PV and other requested SOPs/SDs
•  Supervise the PV system and its quality system
•  Operate and reviewing safety data exchange agreements
•  Supervise internal & external audit and inspection
•  Operate and manage the process of post marketing surveillance and re-examination process
•  Supervise risk minimization activities and additional PV activities
•  Decide the PV scope in the clinical trial planning phase
•  Conduct and/or manage PV activities according to SMP in the clinical trial  
•  Review and approve safety management plan and investigator’s brochure
•  Supervise safety database (global safety database and ICSR tracker) / UAT
•  Supervise data safety monitoring committees (DSMB)
  
  
• Requirements; Education, Qualification and Experience
•  Relevant life sciences degree (such as pharmacy, nurse, biology)
•  Minimum 7 years of experience in Pharmaceutical industry including pharmacovigilance
•  Strong regulatory knowledge including ICH(E2A-E2F), CIOMS, GVP and US CFR
•  High level of understanding pharmacovigilance activities
•  Understanding of corresponding Standard Operating Procedures
•  Computer skills including use of computer, knowledge of Microsoft Word, Excel and PowerPoint preferred
•  Competent in written and oral English
•  Preferred work experience in CRO
•  Preferred Experience writing Aggregate reports (DSUR, PBRER, PSUR) and RMP/RAMS
  
  
• Competency 
•  Excellent interpersonal, verbal and written communication skills
•  Leadership and line management skills
•  Strong influencing and negotiation skills
•  Planning and organizational skills
•  Effective time management in order to meet daily metrics or team objectives
•  Able to take initiative and work independently
•  Consultative skills
•  Ability to make appropriate decisions in ambiguous situations

근무조건

• 고용형태: 정규직(수습기간3개월)
• 급여조건: 회사내규 협의 후 결정

전형단계 및 제출서류

• 전형단계: 서류전형 > 1차 면접진행 > 인성검사진행 > 2차면접진행 > 최종합격
• 추가 제출서류
  이력서, 자기소개서, 포트폴리오 첨부 희망

접수방법

2025-01-31 (금) 23시59분까지

• 접수방법: 인크루트 채용시스템, 자사 홈페이지
• 접수양식: 인크루트 이력서, 자유양식

기타 유의사항

• 입사지원서 및 제출서류에 허위사실이 있을 경우 채용이 취소될 수 있습니다.