The Fountain Group · 6 hours ago
Pharmacovigilance Case Processing Specialist
Cambridge, MA
Contract
Hybrid
Mid Level
4+ years expThe Fountain Group is currently seeking a Pharmacovigilance Case Processing Specialist for a prominent client. The role involves managing the intake and processing of individual case safety reports (ICSRs) from clinical trials and post-marketing sources, ensuring compliance with regulatory requirements.
ConsultingRecruitingStaffing Agency
Responsibilities
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
Qualification
Required
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
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
Preferred
Direct experience with safety databases strongly preferred, including: ArisG, Oracle Argus, Veeva Safety
Benefits
Referral Bonus
Company
The Fountain Group
The Fountain Group is a staffing firm that specializes in rendering contingent workforce solutions to various industries.
501-1000 employees
H1B Sponsorship
The Fountain Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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2025 (52)
2024 (34)
2023 (21)
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2021 (41)
2020 (14)
Funding
Current Stage
Late StageLeadership Team
Jahnavi Patel
Finance Business Partner
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