Description
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 Innovative Medicine and MedTech, 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Product SafetyJob Sub Function:
PharmacovigilanceJob Category:
Scientific/TechnologyAll Job Posting Locations:
Seoul, Korea, Republic ofJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
he Specialist Local Medical Safety, Korea(PV Specialist) is responsible for ensuring that all pharmacovigilance (PV) activities at the Local Operating Company (LOC) are conducted in compliance with local regulatory requirements and company policies at local, regional, and global levels.
This role supports safety reporting, risk management activities, and regulatory compliance to ensure patient safety.
Key Responsibilities
Pharmacovigilance Compliance
- Ensure LOC safety activities comply with local regulations and internal PV procedures
- Support safety reporting activities in accordance with regulatory requirements and company standards
Safety Reporting & Regulatory Support
- Support activities related to safety reporting required by Marketing Authorization Holders (MAH) and/or study sponsors
- Assist in ensuring timely and accurate submission of safety reports
Risk Management Activities
- Support the preparation of Local Risk Management Plans (RMP) and documentation required for license renewal
- Monitor and track implementation of additional risk minimization activities
Training & Awareness
- Ensure proper training documentation on safety reporting responsibilities for LOC personnel
- Maintain awareness and compliance culture around pharmacovigilance processes
Cross-functional Collaboration
- Collaborate with internal stakeholders across functions and regions
- Support cross-functional projects within International Pharmacovigilance (IPV)
Regional / Global Support
- Support compliance-related PV activities in Korea and APAC region
Qualifications
Education
- Bachelor’s degree or above in Health, Life Sciences, Pharmacy, or related field
- Pharmacist license preferred
Experience
- Minimum 2+ years of experience in pharmacovigilance or related areas(e.g., CRA, MIS, Hospital Pharmacist)
- Prior PV experience preferred
Skills & Competencies
- Excellent verbal and written communication skills
- Fluency in the national language(s) and the English language required
- Ability to effectively communicate and negotiate with internal and external customers.
- Ability to establish and maintain relationships within the organization and with authorities
- Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution.
- Must be able to work independently with minimum supervision while meeting tight deadlines
#LI-Hybrid
#LI-SK3
Legal Entity
Innovative Medicine
Job Type
Regular
Application Documents
Free-form resume AND cover letter is required (in Korean or English).
Application Deadline
Open until the position is filled.
Notes
- Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
- Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
- If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
- Submitted documents will not be returned and will be deleted upon request.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Operations, Collaboration, Cross-Functional Collaboration, Detail-Oriented, Execution Focus, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy