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Job Function:

Product Safety

Job Sub Function:

Drug & Product Safety Operations:

Job Category:

Professional

All Job Posting Locations:

Seoul, Korea, Republic of

Job Description:

Employment type

This job position is **fixed-term (Contractor)**employment.

Summary:

The position’s responsibility covers safety vigilance and pharmacovigilance (PV) for medical devices and pharmaceutical products marketed by Johnson & Johnson Med Tech Korea. 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 Med Tech Korea and is responsible for safety-related communication with manufacturers and third parties.

Responsibilities:

1. Acts as Qualified Person for Pharmacovigilance (QPPV)

• 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

• Acts as a registered drug safety manager (의약품 안전관리책임자)

• Supports internal and external initiatives in maintenance and enhancement regarding PV requirements.

Safety Vigilance Activities:

• Monitors all complaints 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

• Reports reportable cases to MFDS by the due dates

• 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(약사) or oriental medicine pharmacist (한약사) 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

Required Skills:Preferred Skills:

Analytical Reasoning, Business Behavior, Clinical Operations, Coaching, Data Reporting, Data Savvy, Detail-Oriented, Medicines and Device Development and Regulation, OSHA Compliance, Problem Solving, Quality Assurance (QA), Quality Control (QC), Report Writing, Risk Compliance, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting