Job Title: Clinical Trial Consultant
Location: Cambridge, Massachusetts (Hybrid)
Job Summary: We are seeking a dedicated professional to support the processing and quality control of clinical trial and postmarket safety cases within a dynamic environment. Our team values precision and timely delivery to advance safety operations and ensure regulatory compliance.
Responsibilities:
- Process, intake, and perform quality control for Individual Case Safety Reports (ICSRs) from clinical trials and assigned postmarket cases.
- Draft narratives, code cases using MedDRA, generate follow-up queries, and notify stakeholders of significant safety events.
- Conduct retrospective quality checks to ensure accuracy and consistency of processed cases and maintain on-time case completion for regulatory reporting.
- Collaborate with Data Management to resolve reconciliation issues, investigate late regulatory submissions, and ensure alignment between safety and clinical databases.
Required:
- Bachelor’s degree in science or a healthcare-related field.
- Minimum of 4 years of experience in pharmacovigilance.
- Proficiency in ICSR processing using safety database systems such as ArisG, Argus, and Veeva.
- Solid understanding of global and local safety regulations, FDA, ICH, and EU requirements for pharmacovigilance, as well as strong written and verbal communication skills.
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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