한성대학교

KENVUE (존슨앤존슨판매유한회사㈜)
주소: 서울특별시 용산구 한강로 2가 LS용산타워(4호선 신용산역 부근) / 300명 / 미국계
* 특이사항: 시간 외 근무수당 지급, 부서 별 상황에 따른 주 2회 재택 근무 가능, 여름 휴가비, 명절 상여금 별도 지급

[근무회사 및 모집부문]

* 근무회사: 신용산역에 위치한 외국계 글로벌 헬스케어 기업 

* 사업분야: 제약, 메디컬, 화장품, 소비재 등

* 모집부서: PV

* 모집부문: PV Specialist

* 높은 인지도의 글로벌 기업에서 외국계 기업에서 PV직무로 커리어 쌓길 희망하는 분들께 추천 드리는 채용 건 입니다.

[Summary]

§ Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners. 

§ The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the ASPAC Region (centralized case management) are carried out in a timely manner.

[Responsibilities]

1) INBOUND & OUTBOUND ICSR CASE MANAGEMENT

§ Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.

§ Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.

§ Data entry for complex cases (seek support from senior specialist as applicable)

§ Assist in the quality review of data captured in the GIRS as applicable

§ Verify and ensure translation of safety information, if applicable.

§ Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.

§ Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.

2) COMPLIANCE MONITORING

§ Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.

3) AUDIT / INSPECTION PREPARATION AND SUPPORT

§ Support the LSO, in matters pertaining to audit or inspection preparation or conduct

4) AGGREGATE REPORTING

§ Support timely submission of aggregate safety reports (e.g. DSUR) to applicable health authorities, in collaboration with local medical safety input (as applicable).

OTHER ACTIVITIES

§ Vendor training, on-going vendor support on a case level (daily or as required),

case review, and vendor oversight (daily or as required)

§ Local literature screening for ICSRs and potential safety signals (in consultation

with local medical safety as needed).

§ Support critical project works

[우대사항]

* 4년제 대졸 이상 (신입 지원 가능)

* PV/RA/QA 경력 1~2년 보유자 선호 (필수 아님)

* 간호사/약사/생명과학 관련 전공자 (우대)

* 영어 능통자 (Speaking & Writing)
* 의학 용어에 대한 이해를 갖춘자 (약물 감시 및 규제에 대한 지식)

[근무환경]

* 계약기간: 1년 파견계약직 (평가에 따른 연장 가능성 보유)

* 근무지: 서울시 용산구 한강로2가(4호선 신용산역 부근)

* 근무시간: 09:00 ~ 18:00 (주 5일 근무)

* 급여: 회사 내규에 따름 (인터뷰 진행 후 경력 및 최종연봉에 따른 결정)

* 특이사항: 부서 상황에 따른 재택근무 가능, 여름 휴가비, 명절 상여금 별도 제공

* 복리후생: 4대보험, 연차, 퇴직금, 경조금, 경조휴가, 통신비 지원금, 명절상여금 등

[지원방법]

* 이메일 지원: eloise.park@manpower.co.kr

* 이메일 제목: PV_본인 성함 기재

* 제출서류: 국/영문 이력서 및 자기소개서 (MS Word 양식)

* 담당자: 박수현, 02-6420-0393