[담당업무]

■ Summary of Job Purpose

ㆍ Manage and conduct PV activities for product life cycle
ㆍConduct the activities for managing PV system and its quality system
ㆍConduct the activities for maintaining domestic and global licensing rights
ㆍCommunicate with Regulatory Authorities

■ Roles and Responsibilities

ㆍEnsure the managing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
ㆍApproval of ICSR based on the results of quality/medical review
ㆍManage expedited and regular reporting to regulatory authorities
ㆍAuthoring and/or reviewing aggregate safety reports (DSUR, PSUR/PBRER), Risk Management Plans, report for Renewal Market Authorization
ㆍSupervise of risk/signal management process
ㆍManage the literature search and approval the results
ㆍSupervise PV training (PV team, company-wide, refresh, advanced etc.)
ㆍReview and approval of training material, assessments, and courses
ㆍDevelop, revise and review the PV and other requested SOPs/SDs
ㆍSupervise the PV system and its quality system
ㆍOperate and reviewing safety data exchange agreements
ㆍSupervise internal & external audit and inspection
ㆍOperate and manage the process of post marketing surveillance and re-examination process
ㆍSupervise risk minimization activities and additional PV activities
ㆍDecide the PV scope in the clinical trial planning phase
ㆍConduct and/or manage PV activities according to SMP in the clinical trial
ㆍ Review and approve safety management plan and investigator’s brochure
ㆍSupervise safety database (global safety database and ICSR tracker) / UAT
ㆍSupervise data safety monitoring committees (DSMB)

■ Requirements; Education, Qualification and Experience

ㆍRelevant life sciences degree (such as pharmacy, nurse, biology)
ㆍMinimum 7 years of experience in Pharmaceutical industry including pharmacovigilance
ㆍStrong regulatory knowledge including ICH(E2A-E2F), CIOMS, GVP and US CFR
ㆍHigh level of understanding pharmacovigilance activities
ㆍUnderstanding of corresponding Standard Operating Procedures
ㆍComputer skills including use of computer, knowledge of Microsoft Word, Excel and PowerPoint preferred
ㆍCompetent in written and oral English
ㆍPreferred work experience in CRO
ㆍPreferred Experience writing Aggregate reports (DSUR, PBRER, PSUR) and RMP/RAMS

■Competency

ㆍExcellent interpersonal, verbal and written communication skills
ㆍLeadership and line management skills
ㆍStrong influencing and negotiation skills
ㆍPlanning and organizational skills
ㆍEffective time management in order to meet daily metrics or team objectives
ㆍAble to take initiative and work independently
ㆍConsultative skills
ㆍAbility to make appropriate decisions in ambiguous situations

■ [우대 사항]
ㆍ제약 등 관련 업계 경력 7년 이상(팀장급)
ㆍPV 경력 5년 이상 선호
ㆍCRO 경력 선호
ㆍMedical Writing (RMP, PBRER, DSUR 등)작성 경험 및 경력 선호

[자격요건]

경력사항: 경력(7년 이상 )
학력사항: 대학교(4년)졸업