Responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature.
• Receive, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
• Perform initial assessment of seriousness, expectedness, causality, and reportability 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
• Identify missing or discrepant information and perform active case follow-up via verbal or written contact
• Prepare expedited reports for submission to regulatory authorities and ethics committees
• 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 pharmacovigilance
• Interface with quality assurance on product quality issues
• Perform reconciliations between clinical, quality and PV databases
• 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 US Periodic Reports, as needed
• Serve as pharmacovigilance resource during inspections and audits
• Healthcare professional (Nurse or Pharmacist) with clinical experience preferred
• Minimum of 3 years of pharmaceutical/biotechnology PV case processing experience, including clinical trial and
post-marketing experience. Global experience preferred. Medical device experience helpful.
• Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review and follow-up
• Proficient in data entry and electronic reporting in global drug safety databases
• Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
• Understanding of Microsoft office applications, specifically Excel and Word
• Must be permitted to work in USA
• Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal
history, and educational background
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.