Drug Safety Specialist

Shanghai - China

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

This job holder is responsible for all activities related to the global case processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing clinical trials and published literature compliance with regulatory and internal company standards. This position may also include activities supporting China PV initiatives within Global Medical Services (GMS) and other tasks upon request.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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.

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Job Description

Job Description

Intake triage and process of adverse event and medical device reports from all sources including post-marketing clinical trials and published literature ensuring accurate and timely handling.
Perform initial assessment of seriousness expectedness causality reportability timeline and special scenarios in accordance with GPV processes and global regulatory requirements and guidelines.
Perform data entry and quality review of adverse event reports into the global safety database including accurate coding of MedDRA terms and preparation of case narratives to ensure the accuracy consistency and compliance.
Identify missing or discrepant case information and determine and conduct appropriate follow-up activities.
Perform reconciliations between clinical quality and PV databases.
Prepare expedited reports for submission to regulatory authorities and ethics committees.
Interface with internal stakeholders for issues/ requests (e.g. with Quality Assurance for product issues or complaints with legal for litigation or claims) and escalate as appropriate.
Serve as pharmacovigilance liaison and resource to internal and external groups (e.g. Regulatory Affairs Medical Affairs Clinical Development teams CROs etc.) on issues related to case processing.
Support safety physicians in handling issues related to both clinical and post-marketing safety as needed.
Support preparation and submission of aggregate reports including PSURs DSURs and PBRERs as needed.
Serve as pharmacovigilance resource during inspections and audits.
Act as liaison between local LSU and global case processing teams to address domestic case related issues.
Provide pharmacovigilance trainings to local staffs and business partners upon request.
Support local response to safety related requests from local Health authority upon request.
Add Chinese translation for domestic cases in GAED to allow for E2b R3 reporting to NMPA upon request.
Ensure archiving of safety data in accordance with regulatory requirement and company SOPs.
Ensure availability of current organization charts job descriptions Curriculum Vitae and training records for safety personnel in the Affiliate(s).
Develop expertized knowledge for pharmacovigilance regulations guidelines and company SOPs and conventions.
Any other tasks assigned by line manager.

Qualifications and Requirements:

Bachelors degree or above major in medicine pharmacy epidemiology or related major
1-2 years of pharmaceutical/biotechnology industry experience in case processing.
Safety database user experience
Familiar with global and local PV regulations and guidelines pertaining to collection processing and reporting of adverse event
Computer literacy (e.g. Microsoft Office software)
Fluency in spoken and written English
Shall be willing to submit to a background investigation including for example verification of past employment criminal history and educational background.

Desired Characteristics:

Sound attention to detail
High integrity sense of urgency ability to recognize time sensitivity
Argus user experience preferred
Ability to identify and solve routine problems independently
Ability to manage multiple priorities
Competent communication skills and able to communicate effectively in a matrix environment.
Being open to change (positive or negative) in response to new information different or unexpected circumstances.
Health Care Professional experience preferred

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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

Required Experience:

Job Description SummaryThis job holder is responsible for all activities related to the global case processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing clinical trials and published literature compliance with regulatory and internal company stand...