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] PV팀(정규직)모집
▣ 의뢰사 : 글로벌 제약사
▣ Position : PV팀 / 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 report and manage safety issues for investigational & marketed products to the headquarter, partners and the regulatory authority within the required timelines.
§ 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 of 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 5 years of experience in drug safety or clinical trial management, Major in pharmacy, Korea Pharmacist
*5년 이상 PV 또는 임상 등 관련 경력
*한국 약사 또는 간호사 면허 소지자
COMPETENCIES:
Good understanding of regulation regarding safety reporting
Good ability in working according to global standards
Good written and spoken English capabilities
Good knowledge of computer software
Good interpersonal skills and communication skills
Good collaboration skills
Good presentation skills
Good conflict management skills
Good change management skills
Good time management skills
Problem-solving skills
Ability to give prioritize tasks
Active and open-minded person to handle multi tasks in the department
Professional and positive attitude
Have strong agility for the self-motivation/development to be a member of high-performing team
▣ 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
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