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 Manager(정규직)모집

▣ 의뢰사 : 글로벌 제약사

▣ Position : PV팀 Manager / 정규직

-주요 업무
PV Operations & Oversight

Oversees all PV activities according to PV Core SOPs or applicable local regulations and guidelines
Oversees Post Marketing Surveillance (PMS) in accordance with local regulations and SOPs
Review and approve PMS protocol and periodic & final reports
Ensure all aggregate reporting-related processes handled by DSKR PV staff
Stakeholder Management

Collaborate with key stakeholders such as strategic partners and health authorities on important drug safety issues in Korea
Engage in interactions, communications, negotiations, and discussions to agree on PV strategies and plans in Korea
Share PV activity performance with global PV
Documentation & Compliance
Review and approve pharmacovigilance SOPs to ensure compliance with applicable regulations
Review and approve RMP (Risk Management Plan) and periodic assessment reports
Review and approve the annual PV training plan
Review and approve PV agreements
Review and approve CAPA plan for audits or inspections
Risk & Resource Management
Risk minimization development/implementation
Compliance management
Procedural documents management including PV agreement
PV strategy/plan development/implementation/oversight
Alignment with Global/ASCA PV policies
Accountable for budget and resource management
Human resource development management
Business Continuity & Records Management
Ensure that a local Business Continuity Process (BCP) for PV is in place
Ensure that records or documents are well-archived and maintained in accordance with SOPs

-모집 구분:
Bachelor's degree or higher in Pharmacy
Minimum 10 years of experience in pharmacovigilance or drug safety
Fluency in Korean and English (both written and spoken)
Proven experience in people management, including leading, coaching, and developing a team in a pharmaceutical or healthcare environment
Strong knowledge of local Korean PV regulations and global PV guidelines (ICH, GVP)
Experience in managing RMP, PMS, and aggregate safety reports
Excellent communication, negotiation, and stakeholder management skills
Strong leadership and project management skills

▣ 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