PV Specialist (안전 관리 책임자)

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.


1. 포지션: PV Specialist (안전 관리 책임자)
2. 근무지: 서울시 용산구
3. 근무 기간: 1년 (평가 후 계약 연장)


[Responsibilities]
1) Key responsibility is to ensure that systems and processes are available for collection, review, reporting and reconciliation of Adverse Events (AEs), Adverse 2) Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
2) Accountable internally for ensuring that the Company meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
3) Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
4) Assure that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
5) Maintain overall responsibility for the coordination of safety requirements as required for Marketing Authorization Holders (MAH).
6) Identify local Medical/Scientific Literature not available to global, review for AEs and report as required per literature reporting criteria.
7) Involvement in implementation of Risk Management Plan, if required. Oversight and tracking of the implementation of core additional risk minimization activities
8) Coordinate the provision of support for third party safety agreements with safety implications at the local level and ensure the safety agreement is implemented locally, as appropriate.
9) Ensure proper documented training on safety reporting responsibilities of Company personnel and maintenance of awareness of safety reporting in general. (safety management and reporting)

[Requirements]
1) Degree in health / science / medical related field (Must pharmacist holder)
2) English proficiency (oral and written)
3) Strong collaboration and interpersonal skills
4) Strategic thinking
5) Results oriented and able to independently create and deliver
6) Strong communication and presentation skills


[JD 확인 및 지원 방법] PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1700205989W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”


[제출 서류]
국&영문 이력서/자기소개서

[서류 마감일] 
채용시 마감


[유의사항] 
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다. 
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com


[이메일 문의]
recruitment-jnj@ITS.JNJ.COM