Drug Safety Intern, Global Case Processing

GE HealthCare

  • Shanghai
  • Training
  • Full-time
  • 13 days ago
Job Description Summary The Drug Safety Intern will support the handling of Individual Case Safety Report (ICSR) in GEHC Global Adverse Event Database (GAED) in compliance with regulatory and internal company standards. This position may also include activities supporting local 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.Job Description
  • Intake of emails in shared mailbox and book-in and triage of certain types of safety reports in GAED in accordance with GPV processes and global regulatory requirements and guidelines, ensuring accurate and timely handling.
  • Perform data entry and quality review of certain types of safety reports in GAED, including coding of MedDRA terms and preparation of case narratives to ensure the accuracy, consistency and compliance.
  • Conduct follow-up activities, including generating and sending out follow-up letters and closing action items in GAED according to company SOPs.
  • Interface with internal stakeholders for issues/ requests and escalate as appropriate.
  • 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).
  • Conduct Regulatory Intelligence tasks according to instruction.
  • Develop knowledge for pharmacovigilance regulations, guidelines and company SOPs and conventions.
  • Any other tasks assigned by line manager.
Inclusion and DiversityGE 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 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.Additional InformationRelocation Assistance Provided: No

GE HealthCare