Drug Safety Specialist - Lumicity : Job Details

Client: Biotechnology Company

Project Details:

• 6-Month contract, 40 hours per week.
• 3 days on-site, 2 days remote.

Responsibilities:

• Adverse Event Case Management - Handle end-to-end processing of clinical and post-market safety cases, ensuring compliance with regulatory and company standards.
• Cross-Functional & Vendor Coordination - Serve as the safety liaison between internal teams and external partners (CROs, call centers, sites) to ensure smooth safety operations.
• Clinical Study Support - Contribute to clinical project teams by reviewing study documents and supporting safety oversight throughout trials.
• Process Improvement & Documentation - Help develop SOPs, safety plans, and quality initiatives to ensure consistent and accurate safety data.
• Regulatory Support - Assist with safety-related regulatory submissions and respond to health authority inquiries as needed.

Requirements

• BS (E.g. RPh/PharmD, BSN, RN).
• 3+ years of experience in drug/clinical safety
• Experience in processing oncology cases (Preferred)
• Demonstrated knowledge of domestic and international regulatory safety reporting requirements