[MedTech] Safety Vigilance Specialist

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/ .

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포지션 : Safety Vigilance Specialist
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계열사 : 존슨앤드존슨 메드테크 (MedTech)
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근무지 : 서울시 용산구
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근무 형태 : Regular

[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]

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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.

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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.

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Stakeholder Engagement: Builds strong, ethical working relationships with third parties and responds to questions or requests in a timely manner.

Shows conviction, ...