[모집 분야] - PV Expert PVE              [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

 [전형 절차]

- 서류전형 > 1차면접 > 인성검사 > 2차면접 > 최종합격

* 필요에 따라 레퍼런스 체크 진행 할 수 있습니다

 

 [제출 서류]
- 이력서 (자기소개서 및 경력 기술서 포함 / 본사 지정 양식 양식)

 

 [근무 조건]

- 근무지 : 서울 강남구 선정릉역 인근

- 처우 조건 : 개별 협의(포괄 임금제)

- 정규직 (3개월 경력 수습-  수습기간 80% 지급)

 

[기타 사항]  허위 사실이 발견될 경우 채용이 취소될 수 있습니다. 

 

 *지원문의*

㈜투비파트너즈 헤드헌터 김희강 상무

전화 : 02 - 759 - 99육4 / 010-육205-94육육(스팸방지 표기 입니다)

이메일 : kimhgang앳(스팸방지 표기 입니다)tbps.co.kr

 

 

◈직접 지원 보다 헤드헌터 이용시 장점◈

- 서류 작성 도움

- 면접과 일정에 대한 정보 제공

- 구직자의 신원 보장

- 헤드헌터는 구직자에게 일체의 사례를 요구하지 않습니다