Job Title: Clinical Trial Consultant II
Location: Cambridge, Massachusetts (Hybrid)
Job Summary:
Our team is seeking a dedicated Clinical Trial Consultant II to play a crucial role in managing case processing and quality control of clinical trial ICSRs and postmarket cases. We are focused on ensuring compliance with global safety regulations and delivering timely and accurate case information to internal stakeholders.
Responsibilities:
- Perform triage, intake, case entry, and quality control of ICSRs from Client-sponsored studies and other assigned cases.
- Draft narrative writing, MedDRA coding, and follow-up queries, ensuring timely event notifications to internal stakeholders.
- Independently manage assigned cases, including weekends and holidays, to ensure on-time regulatory reporting.
- Collaborate with Data Management to resolve reconciliation issues between clinical and safety databases.
Experience/Minimum Requirements:
- Bachelor’s degree in science or healthcare-related field.
- 4+ years of experience in pharmacovigilance.
- Proficiency in ICSR processing using safety database systems such as ArisG, Argus, and Veeva.
- Strong understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU regulations.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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