US_Clinical Trial Consultant II

Overview

The Fountain Group is currently seeking a Pharmacovigilance Case Processing Specialist for a prominent client of ours. This position is located in Cambridge, MA and is hybrid with 2 days onsite required.

• Perform triage, intake, case entry, and quality control (QC) of ICSRs from Biogen-sponsored clinical trials and assigned post-marketing sources.
• Author clear and compliant case narratives, perform MedDRA coding, and draft follow-up queries and event notifications for internal stakeholders.
• Independently manage assigned case workloads, including weekends and holidays, to ensure timely case completion and regulatory submission.
• Conduct retrospective quality checks on processed cases to ensure data accuracy and compliance.
• Review and resolve reconciliation issues between clinical and safety databases in collaboration with Data Management.
• Support investigations related to late regulatory reporting of clinical trial safety cases.

• Bachelor’s degree in a science or healthcare-related field.
• 4+ years of hands-on pharmacovigilance experience, including end-to-end ICSR processing.
• Strong working knowledge of global and local safety regulations, including FDA, ICH, and EU pharmacovigilance requirements.
• Direct experience with safety databases strongly preferred, including ArisG, Oracle Argus, and Veeva Safety.
• Excellent written and verbal communication skills, with experience drafting regulatory-quality narratives.
• Solid understanding of medical terminology, clinical concepts, and medical practices.
• Advanced Microsoft Office skills (Word, Excel, PowerPoint, Outlook).
• Highly organized, detail-oriented, and able to manage multiple cases in a fast-paced, deadline-driven environment.

If you are interested in hearing more about the position, please respond to this posting with your resume attached. Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.