1. 소속 헤드헌팅 회사명: 제이에이치에이치알-JHHR /
2. 소속 헤드헌팅사 홈페이지: http://www.jhhr.co.kr
3. 소속 헤드헌팅사 회사용, 이메일 : jhkwak@jhhr.co.kr
4. 포지션 진행 헤드헌터명 및 직급 : 곽 지 혜 대표 컨설턴트
5. 진행 포지션명(간단 기재):
6. 상세 포지션 내용 :

[글로벌제약사] PV 팀원 모집

▣ 의뢰사 : 글로벌 제약사

▣ Position : PV 팀원 / 정규직

-주요 업무
[1] Pharmacovigilance Area
§ To carry out PV activities in a proper and timely manner in accordance with the relevant regulations, SOPs and Code of Practice.
§ To report and manage Individual Case Safety Reports (ICSRs) for investigational and marketed products to the headquarter, partners and the regulatory authority within the required timelines.
- Receive and triage of ICSRs;
- Track and file ICSRs;
- Communicate for ICSRs;
- Conduct ICSRs reporting;
- Follow-up on additional information;
- Handle ICSRs-related inquiries;
§ To collect adverse events of investigational & marketed products and safety issues from various sources (e.g. literature, MIS query, media, HCP, patient, clinical study and etc.).
§ To communicate with the regulatory authority and the headquarter for safety issues properly.
§ To monitor regulatory changes related to PV in a timely manner and take appropriate actions to cope with the changes by analyzing their impact on the business.
§ To cooperate with RA for handling product complaints and safety related issues regarding labeling changes.
§ To collaborate with relevant parties for global and local clinical trials (e.g. safety related document review, SAE reconciliation and SAE flow plan).
§ To prepare and maintain PV agreement with co-promotional companies and to ensure their compliance with PV.
§ To prepare and execute the Risk Management Plan (RMP) properly.
§ To conduct and/or support active surveillance (e.g. PMS) as part of the RMP.
§ To prepare and submit aggregated reports (e.g. PSUR/PBRER, DSUR) in a timely manner.
§ To prepare safety data for product renewal.
§ To conduct or support PV training for all employees in a timely and efficient manner.
§ To support or manage the product liability issues.
§ To develop and maintain relevant SOPs for PV activities in accordance with global/Asia regional SOPs and regulations.
§ To manage PV system and data.
§ To collaborate with the headquarter and relevant functions like MR, MKT, MIS and IT for PV activities.
§ To perform other miscellaneous administrative tasks

-모집 구분:
§ Requirement: At least 3 years of experience in PV or related area
§ Preferrence: Masters/Bachelors level degree in health science, pharmacy and Nursing etc.

▣ 연봉수준 및 복리후생: 현, 연봉 수준이상 추후 협의 가능 / 주5일제 / 4대 보험 등

▣ 근무지 : 서울

▣ 제출 서류 : 국문 이력서 또는 영문 CV

▣ 담당자: 곽 지 혜 컨설턴트
이메일 : jhkwak@jhhr.co.kr