셀타스퀘어 는

약물감시(Pharmacovigilance) 분야의 전문 서비스와 AI/Digital Platform을 제공하는 Safety Data 전문기업입니다.

국내 유일의 Oracle Argus Partner로서 글로벌 표준 안전성 데이터베이스  Argus Safety 를 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/RAMS

우대사항

 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

전형절차

서류전형 > 역량검사 & 1차면접 > 2차면접 > 처우협의 > 최종합격(수습 3개월)

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