포지션 상세
약물감시 (Pharmacovigilance) 분야의 전문 서비스와 AI/Digital Platform을 제공하는 회사 입니다.
국내 유일의 Oracle Argus Partner로 Argus Safety Database를 공급 & 도입을 제공하고 있습니다.
국내 제약 시장 뿐만 아니라, 글로벌 제약 시장을 Target으로 시장을 확대하고 있습니다.
현재 대웅제약, 유한양행, 존슨앤드존슨등 빅파마를 Sponsor로 하고 있습니다.
25년 시리즈A 98억 규모 투자 완료하여 Scale-up을 함께할 인재를 찾고 있습니다.
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)
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
국내 유일의 Oracle Argus Partner로 Argus Safety Database를 공급 & 도입을 제공하고 있습니다.
국내 제약 시장 뿐만 아니라, 글로벌 제약 시장을 Target으로 시장을 확대하고 있습니다.
현재 대웅제약, 유한양행, 존슨앤드존슨등 빅파마를 Sponsor로 하고 있습니다.
25년 시리즈A 98억 규모 투자 완료하여 Scale-up을 함께할 인재를 찾고 있습니다.
주요업무
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
