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채용정보
채용포지션 : [약물 감시 전문 기업] PV Expert PVE
2025-03-14
조회수 : 1750
- Summary of Job Purpose
- * Manage and conduct PV activities for product life cycle
- * Conduct the activities for managing PV system and its quality system
- * Conduct the activities for maintaining domestic and global licensing rights
- * Communicate with Regulatory Authorities
- Roles and Responsibilities
- * 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)
- Requirements; Education, Qualification and Experience
- * 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
- Competency
- * 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
- · 헤드헌터 : 김희강 / 상무
- · 전화번호 : 02-759-9964
- · 이메일 : kimhgang@tbps.co.kr
- · 상태 : 마감