General Electric Drug Safety Specialist - Korea in Seoul, South Korea
Job Description Summary
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
[Inclusion and Diversity]
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
[Roles and Responsibilities]
Responsible for implementing and maintaining the national pharmacovigilance system according to the current pharmacovigilance agreement between the local GE Healthcare office and the global GE Healthcare pharmacovigilance organization.
GE Healthcare Korea, PDX(조영제) 사업부에서 Drug Safety Specialist 약사 인재를 채용합니다.
담당업무는 약물감시(PV), 식약처 커뮤니케이션, Global Audit 대응, 국내 규정 적용/추가 등 관리, 안전성 보고관리, 협업부서(특히 영업부)와 긴밀한 커뮤니케이션, 부작용 사례 전달/보고, 문서/Data 관리 등의 업무입니다.
안전관리자 책임 선임 가능자 (약사 or 의사 자격증 소지자)
업무상 영어활용에 큰 부담 없는 분 (Reporting to 외국인)
관련경력 5년 이상
A key position that is responsible for management of pharmacovigilance of marketed products and clinical trials in Korea and other regions as needed. The position includes ensuring compliance with all global pharmacovigilance requirements and all local regulations, together with identification/ implementation of suitable risk management plans for maintaining high governance standards. This position may also include activities supporting global compliance initiatives within Global Pharmacovigilance (SOP management, training).
Ensure PV compliance
Management of localized PV SOPs
Training of all operating company staff, new hiring, relevant and 3rd party vendors including Agencies & CRO in adverse event reporting
Archive all safety relating documents
Assist in audits and inspections
Ensuring that the national pharmacovigilance is compliant with national laws
Monitor new PV requirements and proactively provide stakeholders with PV guidance.
Adverse Events Reports
Collecting, recording, processing, translating and submitting AEs from all sources, including PMS, QA and Medical Information, to Central Safety Unit (CSU) in compliance with local regulations and GEHC policy.
Ensure local language medical or scientific literature are reviewed to identify possible adverse events or special situations reportable to CSU, and that any reports are forwarded in a timely manner to CSU.
Maintaining an archiving system for pharmacovigilance and safety related information
Establishing and maintaining a system which allows to detect, collect and process on a national level adverse events, reports
Safety management from Clinical trials
Review of PV-related issues of protocols and other documents
Manage the handling and reporting of pharmacovigilance related matters used in clinical trials.
Providing pharmacovigilance support for contracts/agreement negotiations for clinical trials.
Serving as the deputy point of contact within the GEHC AS Korea for management of safety issues:
Management of safety related enquiries
Attending PV related conferences and training programs
Establishment and Implementation of Risk Management Plan (RMP)
Developing risk-management strategies to submit RMP with GPV for regulatory approval as part of its application process and liaising with other local stakeholders to implement RMP responsible for proper documentation of the process through the creation of Standard Operating Procedures (SOPs)
Collaborates with Regulatory Affairs and other functional teams to compile RMP submissions and reports to the MFDS for approval; leads the response to MFDS questions and requests for additional information during RMP negotiations.
Develops and maintains department Standard Operating Procedures (SOPs) and working practices to support RMP implementation.
Collaborates with key stakeholders on the creation of communications, materials, and documentation for RMP activities.
Monitors external environment for regulatory changes impacting risk management.
Sets and manages overall timelines
Support of PV activities for business partners and distributors of GEHC AS Korea
Preparing or reviewing safety data exchange agreements with third parties / business partners
Submission of foreign SADR by due date
Act as contact point for safety documents submissions such as Periodic Reports where required by local regulations
Management Adverse Drug Reaction(ADR) Relief System
Management of charge allotment for the system
Liaise and communicate with internal stakeholders and health authorities for management when the safety issues regarding relief injury from ADR are requested
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.