<h2>직무</h2><p>PV Expert (PVE)</p><h2>포지션 상세</h2><p>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 98억 규모 투자 완료하여 Scale-up을 함께할 인재를 찾고 있습니다.</p><h2>주요업무</h2><p>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, 최대 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>리프레쉬데이</p>
