GE HealthCare Drug Safety Specialist 

China, Shanghai 

873641708

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 etc. in 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.

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 China 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:

• Bachelor’s 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

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.