描述
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/.
1. 포지션: Safety Vigilance Specialist - Pharmacovigilance(Pharmacist)
2. 계열사: 존슨앤드존슨 메드테크 (MedTech)
3. 근무지: 서울시 용산구
4. 근무 형태: Regular
[Summary]
The positions responsibility covers safety vigilance and pharmacovigilance (PV) for medical devices and pharmaceutical products 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. Incumbent is also involved in safety and PV activities related to product launches, physician education, sales training, and incident investigation. The incumbent is the QPPV (; Qualified Person for Pharmacovigilance) for pharmaceutical products distributed by J&J MedTech in North Asia market and is responsible for safety-related communication with manufacturers and third parties.
[Responsibilities]
1. Acts as Qualified Person for Pharmacovigilance (QPPV) for North Asia
- Conducts required PV activities according to the relevant J&J standards and local regulations e.g. Set up agreement with manufacturers on PV requirements, share safety information, conduct local literature review, prepare PMS data, conduct PV training to internal and external stakeholders, monitor and report relevant cases to MFDS
- (Korea market only) Acts as a registered drug safety manager ( 의약품 안전관리책임자)
- Supports internal and external initiatives in maintenance and enhancement regarding PV requirements.
2. 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
[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
- (Mandatory) Pharmacist is required
- Understanding in Korea Pharmaceutical Affairs Act regarding drug import business
- Knowledge in safety vigilance requirements in healthcare industry
- Proficient in English both verbal and written communication
- Excellent communication and interpersonal skills
Preferred
- Job experiences in a highly regulated industry (e.g., medical devices, pharmaceutical products, OTC and/or Cosmetics)
- Job experience in handling Drug and/or Biologics
[ 지원 방법]
www.careers.jnj.com 접속 -> Position Number 2406224805W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
[ 제출 서류]
국& 영문 자유 양식의 이력서/ 자기소개서
[ 서류 마감일]
채용시 마감
[ 유의사항]
- 국가 보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.
- 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.
资格
See above.