Job Description Summary

Primarily 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. Additionally, as a more advanced case processor, responsible for activities that support training, compliance, regulation changes, and the shaping of process improvements.

Job Description

Essential Responsibilities

• Receive, triage and process adverse events 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
• Review 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, Quality Assurance, clinical development teams, CROs, etc.)
• 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 and subject matter expert during inspections and audits
• Vendor oversight as needed, collaborating with external project leaders and teams to develop solutions, provide appropriate training, and monitor quality
• Provide oversight of clinical trials, requesting study configurations and developing study-specific job aids, as needed.
• Oversee workflow management and case prioritization to maintain compliance with regulatory timelines
• Provide Compliance group with root cause analysis and CAPA for late submissions
• Troubleshoot questions and issues with team, including database functionality, case processing conventions, and report submission failures; provide guidance based on experience and Data Handling Conventions
• Assist with writing and updating of SOPs and other guidance documents, in response to process improvements or changing regulations
• Participate in database projects and user acceptance testing, as needed, providing insight from business / case processing perspective