PV Expert (PVE)

셀타스퀘어는 약물감시(Pharmacovigilance) 분야의 전문 서비스와 AI/Digital Platform을 제공하는 Safety Data 전문기업입니다. 국내 유일의 Oracle Argus Partner로서 글로벌 표준 안전성 데이터베이스 Argus Safety를 공급하고 있으며, 대웅제약, 유한양행, 존슨앤드존슨 등 주요 제약사들과 함께하고 있습니다. 2025년 Series A 92억 원 투자 유치를 완료하고, 글로벌 시장 확장을 위한 본격적인 스케일업 단계에 있습니다.담당업무 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)자격요건 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/RAMS우대사항 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 situations전형절차서류전형 > 역량검사 & 1차면접 > 2차면접 > 처우협의 > 최종합격(수습 3개월)제출서류 : 이력서(현재연봉, 희망연봉 기재)서류 합격자에 한해 연락드립니다.