[모집개요]
회사 : 외국계제약회사
포지션 : PV-CR Associate
회사위치 : 서울
[모집부문]
직위 : 대리급
담당업무 : PV – CR(Clinical research) Associate/외국계제약회사

외국계 제약회사에서 PV – CR(Clinical research) Associate 를 찾고 계십니다.
주요 업무는 아래와 같습니다.

Main Accountability
• Manage collection, processing, documentation, reporting and follow-up of all adverse event (AE) reports and adverse drug reactions (ADR) for all the Company’s products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
• Ensure recording and tracking of receipts/submissions/distributions of Individual Case Safety Reports (ICSR), Serious Adverse Events (SAEs), Investigator Notifications (IN), Periodic Safety Report Updates (PSUR) and Annual Safety Reports (ASR) and ensure reporting/submission/distribution of safety re-ports/updates/information (e.g. ICSR, SAE, IN, PSUR ASR, changes in risk benefit) to local Health Au-thorities (HA) according to regulatory requirements.
• Management and maintenance all local relevant PV databases.
• Ensure appropriate agreements are in place for local licensor or licensee to comply with all require-ment for reporting ADRs/AEs.
• Participate in local/regional clinical operations activities and local business meetings as required.
• Interact with CRO s and develop alliance with preferable CROs for ensuring qualified clinical operation.
• Supervise overall project performance in a team and ensure qualities through co-visit and co-monitoring.
• Responsible for implementing of assigned clinical trials as a project owner.
• Manage and support CRA s in all clinical operation activities and issues.
경력요건 : Requirements :

1. PV경력 2년이상의 분
2. PV + CR 경력 가지고 계신분 선호합니다.
3. 약학전공자
4. 영어 가능하신 분
연령 : .
학력 : .
어학 : .
컴퓨터 : .
연봉 : .
특이사항 : .
[담당자/문의처]
담당자 : 원현숙상무
전화 : 02-2050-0299
제출서류 : 국영문이력서
전자우편 : hs@mstone.co.kr