[서울역] GEHC PV specialist (1Y 3M/육휴대체) | (주)맨파워그룹코리아

[서울역] GEHC PV specialist (1Y 3M/육휴대체) | (주)맨파워그룹코리아

[서울역] GEHC PV specialist (1Y 3M/육휴대체) | 기타 바이오/제약 (Pharma/CTA, PV, RA, etc.) | 경력 무관 | 계약직 | GEHC | 상시 채용

[회사소개] GE 헬스케어 는 에디슨이 설립한 기업인 미국의 다국적 대기업 제너럴 일렉트릭 의 자회사로 뉴욕 에 설립되었으며 본사는 일리노이주 시카고에 있습니다. 2017년 기준으로 의료영상 시술에 사용되는 영상 진단용 영상진단제 및 방사성의약품 을 제조 및 유통하고 있습니다. 자기 공명 영상 절차 에 사용되는 염료를 제공 합니다. CT 영상 기계 를 포함한 의료 진단 장비 제조 ; MRI, 엑스레이; 초음파; 캐스 연구소; 유방 조영술; 핵의학 카메라; 의료 영상 및 정보 기술 을 위한 건강 기술 개발, 의료 진단 , 환자 모니터링 시스템 , 질병 연구 , 약물 발견 및 생물 의약품 제조 . 1994년에 설립되었으며 100개 이상의 국가에서 운영되고 있습니다. * 본 채용건은 PV 경력 2년 이상 지원자를 대상으로 하고있습니다. [모집분야 및 업무내용] Description: The job holder is responsible for implementing and maintaining the national pharmacovigilance system according to the current pharmacovigilance agreement between the local GE Healthcare office and the global GE Healthcare pharmacovigilance organization. Primary responsibilities include: A key position that is responsible for management of pharmacovigilance of marketed products and clinical trials in Korea and other regions as needed. The position includes ensuring compliance with all global pharmacovigilance requirements and all local regulations, together with identification/ implementation of suitable risk mitigation strategies for maintaining high governance standards. This position may also include activities supporting global compliance initiatives within Global Medical Services (SOP management, training). Ensure PV compliance • Registered Pharmacist as a Safety Management Officer of GEHC AS Korea • Management of localized PV SOPs • Training of all operating company staff, new hiring, relevant and 3rd party vendors including Agencies & CRO in adverse event reporting • Assist in audits and inspections • Ensuring that the national pharmacovigilance is compliant with national laws Adverse Events Reports • Collecting, recording, processing, translating and submitting AEs from all sources to CSU in compliance with local regulations and GEHC policy. • Ensure local language medical or scientific literature are reviewed to identify possible adverse events or special situations reportable to CSU, and that any reports are forwarded in a timely manner to CSU. • Maintaining an archiving system for pharmacovigilance and safety related information • Establishing and maintaining a system which allows to detect, collect and process on a national level adverse events, reports • Follow the instructions of global RA concerning PSUR submissions and renewals Safety management from Clinical trials • Review of PV-related issues of protocols and other documents • Manage the handling and reporting of pharmacovigilance related matters used in clinical trials. • Providing pharmacovigilance support for contracts/agreement negotiations for clinical trials. Serving as the deputy point of contact within the GEHC AS Korea for management of safety issues: • Management of safety related enquiries • Review promotional material from the perspective of pharmacovigilance • Attending conferences and training programs Establishment and Implementation of risk management plan • Developing risk-management strategies to submit RMP for regulatory approval as part of its application process and liaising with other local stakeholders to implement RMP responsible for proper documentation of the process through the creation of Standard Operating Procedures (SOPs) • Collaborates with Regulatory Affairs and other functional teams to compile RMP submissions and reports to the MFDS for approval; leads the response to MFDS questions and requests for additional information during RMP negotiations. • Develops and maintains department Standard Operating Procedures (SOPs) and working practices to support RMP implementation. • Collaborates with key stakeholders on the creation of communications, materials, and documentation for RMP activities. • Monitors external environment for regulatory changes impacting risk management. • Sets and manages overall timelines Support of PV activities for business partners and distributors of GEHC AS Korea • Preparing or reviewing safety data exchange agreements with third parties / business partners • Training of staff of business partners • Performing applicable quality checks of local cases before reporting to CSU and regulatory Authority • Screening of local literature of MI products for Adverse Drug Reactions other relevant safety data on a weekly basis or according to journal publications. • Support reporting of foreign SADR • Act as contact point for submissions such as PSURs where required by local law Management Adverse Drug Reaction (ADR) Relief System • Management of charge allotment for the system • Liaise and communicate with internal stakeholders and health authorities for management when the safety issues regarding relief injury from ADR are requested Management of Foreign SADR • coordinate with the global operation team to process foreign SADRs cases required by Korean regulatory authorities. • Report all foreign SADRs to regulatory authorities Monthly adverse event Reconciliation of • cooperation with the global team to confirm monthly reconciliation regarding the receipt of adverse events Qualification / Requirement - Licensed Pharmacist required - At least 2years PV and drug safety experience - Bachelor's Degree in Pharmacy, Scientific or healthcare discipline or allied life sciences - Knowledge of national and international regulations for pharmacovigilance - Knowledge of pharmacological and medical terminology. - Quality and focus oriented - Computer skills 근무형태> · 채용 기간 : 2024.3월~2025.6월(1년 3개월) 산휴대체 · 근무지: 서울/서울 중구 한강대로 416 서울스퀘어 (15층) - 고용형태: 맨파워코리아 소속 파견계약직- 급여조건: 회사 내규에 따름 (경력별 협의) - 근무요일: 월-금 - 근무시간: 09:00 - 18:00 (업무에 따라 재택근무 병행 가능) ※ 취업보호 대상자(국가보훈대상자 등)는 관련 법령에 따라 우대※ 해외여행 결격사유가 없는 자 (단, 남자는 병역필 또는 면제자) [전형절차] 서류 지원 -> 맨파워 상담 -> 지원 기업 서류 전형 -> 지원 기업 면접 전형 -> 최종 합격 ※ 전형 절차는 채용 건 별로 차이가 있을 수 있습니다. [지원서류]- word 양식의 국문 이력서 및 자기소개서, 영문 이력서 [지원방법]- '지원하기' 클릭! - 문의사항: SS1 이지원 (elly.lee@manpower.co.kr) / 02-568-0174