At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
[Summary]
The position’s responsibility covers safety vigilance for medical devices marketed by Johnson Johnson MedTech in North Asia market (Korea, 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. This position is also responsible for AE reporting to MFDS for reportable domestic and overseas cases.
[Responsibilities]
Safety Vigilance Activities
- Monitors all complaints in North Asia market in Enterprise Complaint Management (ECM) system on a regular basis to ensure all Adverse Events or urgent safety issues are addressed.
- Determines reportability of complaints as per the local regulations in North Asia market.
- Reports reportable cases to MFDS by the due dates and ensures HK and TW cases to be reported by the local personnel in a timely manner.
- Provides safety expertise, when necessary, e.g. customer interactions
- Supports internal and external initiatives in maintenance and enhancement regarding safety vigilance activities.
- Be responsible for overseas serious adverse events reporting: e.g. Extract relevant data from ECM, translate the data to ensure alignment with the local regulations and standards, reports the data to MFDS by the due dates
- Communicate with health authorities to address any clarifications or additional information requested.
- Maintain comprehensive traceability of all regulatory submissions including details
[Leadership Competencies]
1. Scientific and Technical Leadership: Uses knowledge of scientific principles to ask right questions to make a pertinent reportability decision of all complaints. Exhibits curiosity and deep passion to continuously learn about new medical and scientific developments and technological platforms.
2. Statistical Knowledge and Analysis: Leverages knowledge of statistics to monitor the regulatory report trend. If there is any outlier found, escalates the trend and proactively communicates with medical director and safety regional and global team if necessary.
3. Stakeholder Engagement: Builds strong, ethical working relationships with third parties and responds to questions or requests in a timely manner. Shows conviction, proactivity, and persistence to gain commitment on their request. Provides technical education and training to various internal and external stakeholders to build organizational capabilities.
4. Medical Safety Monitoring: Represents the organization in safety-related settings by providing medical information for a product/medical procedure and the implications of its use. Critically evaluates the safety profile of new and existing products/medical procedures to maximize patient safety outcomes. Collaborate with functional partners to develop ongoing safety surveillance programs for products/medical procedures from development to post market surveillance. Leverages medical knowledge to provide unique insights into product/medical procedure safety outcomes and organizational processes and respond to requests for medical safety information. Provides recommendations based on thorough risk-benefit analysis, including the assessment of potential patient safety issues.
5. Risk management: Helps the organization systematically evaluate product/medical procedure risks and benefits as part of a comprehensive risk management approach. Enhances the product/medical procedure safety process by ensuring prompt investigation and resolution of potential patient safety issues.
[Requirements]
Required
- Understanding in Medical Device Act regarding medical device import business
- Knowledge in safety vigilance requirements in healthcare industry
- Proficient in English both verbal and written communication
- Excellent communication and interpersonal skills
- Basic understanding in medical terminology and environment
Preferred
- Medical and scientific background e.g. major in pharmacy, nursing, life science, biology and similar.
- Job experiences in a highly regulated industry (e.g., medical devices, pharmaceutical products, OTC and/or Cosmetics)
[지원 방법]
www.careers.jnj.com 접속 -> Position Number 2406221547W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
[제출 서류]
국영문 자유 양식의 이력서/자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 국가 보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
- 서류전형합격자에한하여개별통보합니다.단,회사사정에따라지연될수있습니다.
- 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.
- 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
[Summary]
The position’s responsibility covers safety vigilance for medical devices marketed by Johnson Johnson MedTech in North Asia market (Korea, 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. This position is also responsible for AE reporting to MFDS for reportable domestic and overseas cases.
[Responsibilities]
Safety Vigilance Activities
- Monitors all complaints in North Asia market in Enterprise Complaint Management (ECM) system on a regular basis to ensure all Adverse Events or urgent safety issues are addressed.
- Determines reportability of complaints as per the local regulations in North Asia market.
- Reports reportable cases to MFDS by the due dates and ensures HK and TW cases to be reported by the local personnel in a timely manner.
- Provides safety expertise, when necessary, e.g. customer interactions
- Supports internal and external initiatives in maintenance and enhancement regarding safety vigilance activities.
- Be responsible for overseas serious adverse events reporting: e.g. Extract relevant data from ECM, translate the data to ensure alignment with the local regulations and standards, reports the data to MFDS by the due dates
- Communicate with health authorities to address any clarifications or additional information requested.
- Maintain comprehensive traceability of all regulatory submissions including details
[Leadership Competencies]
1. Scientific and Technical Leadership: Uses knowledge of scientific principles to ask right questions to make a pertinent reportability decision of all complaints. Exhibits curiosity and deep passion to continuously learn about new medical and scientific developments and technological platforms.
2. Statistical Knowledge and Analysis: Leverages knowledge of statistics to monitor the regulatory report trend. If there is any outlier found, escalates the trend and proactively communicates with medical director and safety regional and global team if necessary.
3. Stakeholder Engagement: Builds strong, ethical working relationships with third parties and responds to questions or requests in a timely manner. Shows conviction, proactivity, and persistence to gain commitment on their request. Provides technical education and training to various internal and external stakeholders to build organizational capabilities.
4. Medical Safety Monitoring: Represents the organization in safety-related settings by providing medical information for a product/medical procedure and the implications of its use. Critically evaluates the safety profile of new and existing products/medical procedures to maximize patient safety outcomes. Collaborate with functional partners to develop ongoing safety surveillance programs for products/medical procedures from development to post market surveillance. Leverages medical knowledge to provide unique insights into product/medical procedure safety outcomes and organizational processes and respond to requests for medical safety information. Provides recommendations based on thorough risk-benefit analysis, including the assessment of potential patient safety issues.
5. Risk management: Helps the organization systematically evaluate product/medical procedure risks and benefits as part of a comprehensive risk management approach. Enhances the product/medical procedure safety process by ensuring prompt investigation and resolution of potential patient safety issues.
[Requirements]
Required
- Understanding in Medical Device Act regarding medical device import business
- Knowledge in safety vigilance requirements in healthcare industry
- Proficient in English both verbal and written communication
- Excellent communication and interpersonal skills
- Basic understanding in medical terminology and environment
Preferred
- Medical and scientific background e.g. major in pharmacy, nursing, life science, biology and similar.
- Job experiences in a highly regulated industry (e.g., medical devices, pharmaceutical products, OTC and/or Cosmetics)
[지원 방법]
www.careers.jnj.com 접속 -> Position Number 2406221547W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
[제출 서류]
국영문 자유 양식의 이력서/자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 국가 보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
- 서류전형합격자에한하여개별통보합니다.단,회사사정에따라지연될수있습니다.
- 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.
- 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.
See above.
See above.