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- 계열사: 존슨앤드존슨메디칼 (Medical Devices)
- 포지션: Safety Vigilance Specialist (Pharmacist)
- 근무지: 서울시 용산구
- 근무형태: 정규직 (Regular)
This position is a medical safety officer for Johnson and Johnson & Johnson medical Korea. The positions responsibility covers safety vigilance for all medical devices sold by Johnson & Johnson in Korea(MTR), Hong Kong, and Taiwan. Incumbent is responsible for monitoring and reporting events related to product and patient safety to internal departments and local health authorities. Incumbent will also be involved in safety activities related to product launches, physician education, sales training, and incident investigation. This position will be responsible for Pharmacovigilance about Evicel and communicating with third parties. (Omrix and Dalim)
1. Monitors all the complaints in KR(MTR), HK and TW.
- Monitor Complaint systems every day in order to ensure no AE or urgent safety issue are missed, and to maintain deadlines for AE, SAE or death
- Taiwan and Hong Kong complaints review and determine whether it is reportable case or not.If the complaint is reportable case, communicate with Taiwan business quality team to let them report this complaint to the Health Authority in a timely manner.
- Archive Taiwan and Hong Kong complaints file weekly and have the alignment activity with Manager.
- Review the Korea mentor complaints and report the adverse event to Local Health Authority. After reporting, complete the unity determination activity and attach the report.
2. Overseas serious adverse event reporting
- Download overseas serious adverse event of all franchise from the ECM. Forward this organized file to outsourcing vendor people.
- After they send the translation file, review the file. And send back this file to them to report.
- Do the payment process regularly
3. Do the Evicel related safety activity (Pharmacovigilance)
- PRISM site management for EVCEL adverse event determination
- Have the alignment communication with “Dalim” monthly.
- Report the overseas adverse event captured from LCRx program to KIDS.
- Do the local literature review monthly.
- Have the meeting with Omrix bimonthly
- Provide training to internal business teams as well as external partners about the pharmacovigilance training as needed
4. Document all the related information of complaints and AEs and maintains relevant internal database. And provide monthly data input for the regional safety data
5. Attend Monthly Medical safety call
6. Safety related SOP create and revision
- Pharmacist is required
- High speaking and writing proficiency in English
- Medical and scientific background is needed to interpret and understand “next steps” in AE or SAEs, investigations.
- Must demonstrate excellent mental agility in understanding a wide breath of medical conditions and surgical solutions.
- Basic understanding of Imaging, such as X-ray, CT or video
- Understand potential patient consequence and severity of AE on patient outcomes relatedness to products
- Clear leadership ability to engage with internal and external partners as part of basic investigations as well as larger safety projects and management across the cluster and with regional and global teams.
- Willingness to travel with in the cluster and AP approximately 15%
www.careers.jnj.com 접속 -> Position Number 2005800216W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
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Johnson & Johnson Medical Korea (Ltd.) (7225)