<h2>직무</h2><p>PV Expert (PVE) / 7년 이상</p><h2>포지션 상세</h2><p>셀타스퀘어는,<br>• 약물감시 (Pharmacovigilance) 분야의 전문 서비스와 AI/Digital Platform을 제공하는 회사 입니다.<br>• 국내 유일의 Oracle Argus Partner로 Argus Safety Database를 공급&도입을 제공하고 있습니다. <br>• 국내 제약 시장 뿐만 아니라, 글로벌 제약 시장을 Target으로 시장을 확대하고 있습니다.<br>• 현재 대웅제약, 유한양행, 존슨앤드존슨등 빅파마를 Sponsor로 하고 있습니다.<br>• 25년 시리즈A 92억 규모 투자 완료하여 Scale-up을 함께할 Sales 인재를 찾고 있습니다.</p><h2>주요업무</h2><p>Summary of Job Purpose<br>* Manage and conduct PV activities for product life cycle<br>* Conduct the activities for managing PV system and its quality system<br>* Conduct the activities for maintaining domestic and global licensing rights<br>* Communicate with Regulatory Authorities<br><br>Roles and Responsibilities<br>* Ensure the managing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.<br>* Approval of ICSR based on the results of quality/medical review<br>* Manage expedited and regular reporting to regulatory authorities<br>* Authoring and/or reviewing aggregate safety reports (DSUR, PSUR/PBRER), Risk Management Plans, report for Renewal Market Authorization<br>* Supervise of risk/signal management process<br>* Manage the literature search and approval the results<br>* Supervise PV training (PV team, company-wide, refresh, advanced etc.)<br>* Review and approval of training material, assessments, and courses<br>* Develop, revise and review the PV and other requested SOPs/SDs<br>* Supervise the PV system and its quality system<br>* Operate and reviewing safety data exchange agreements<br>* Supervise internal & external audit and inspection<br>* Operate and manage the process of post marketing surveillance and re-examination process<br>* Supervise risk minimization activities and additional PV activities<br>* Decide the PV scope in the clinical trial planning phase<br>* Conduct and/or manage PV activities according to SMP in the clinical trial <br>* Review and approve safety management plan and investigator’s brochure<br>* Supervise safety database (global safety database and ICSR tracker) / UAT<br>* Supervise data safety monitoring committees (DSMB)</p><h2>자격요건</h2><p>* Relevant life sciences degree (such as pharmacy, nurse, biology)<br>* Minimum 7 years of experience in Pharmaceutical industry including pharmacovigilance<br>* Strong regulatory knowledge including ICH(E2A-E2F), CIOMS, GVP and US CFR<br>* High level of understanding pharmacovigilance activities<br>* Understanding of corresponding Standard Operating Procedures<br>* Computer skills including use of computer, knowledge of Microsoft Word, Excel and PowerPoint preferred<br>* Competent in written and oral English<br>* Preferred work experience in CRO<br>* Preferred Experience writing Aggregate reports (DSUR, PBRER, PSUR) and RMP/RAMS</p><h2>우대사항</h2><p>* Excellent interpersonal, verbal and written communication skills<br>* Leadership and line management skills<br>* Strong influencing and negotiation skills<br>* Planning and organizational skills<br>* Effective time management in order to meet daily metrics or team objectives<br>* Able to take initiative and work independently<br>* Consultative skills<br>* Ability to make appropriate decisions in ambiguous situations</p><h2>혜택 및 복지</h2><p>✨개인의 성장은 곧 회사의 성장<br>자기 계발을 위한 세미나, 컨퍼런스, 교육 참가비 지원 <br>업무시 필요한 프로그램 지원<br>최신형 노트북 및 모니터 지원<br>전사 목표 달성 시, 월급 1개월분의 인센티브 지급<br><br>🕗업무시간의 유연성<br>오전 8시~오전 10시 자율출퇴근제<br>주 1회 집중근무<br>연차/반차/시차 자유로운 연차 사용<br><br>🎠휴가<br>여름, 겨울 5일씩 휴가갑니다~<br>출산 및 육아휴직<br>건강검진 반차<br><br>☕든든한 지원<br>사내 커피머신 비치, 간식 지원<br>각종 경조사 및 경조휴가 지원<br>패밀리데이(매월 마지막주 금요일 전체회의 후 조기퇴근)</p>
