Position : Drug Safety Specialist
Location : Waltham, MA (Hybrid)
Experience: 3 - 5 Years
Type : Long-term Contract (Potential for Extension)
We're looking for a Drug Safety Specialist with strong clinical experience and a solid background in oncology and pharmacovigilance. You'll be responsible for end-to-end case processing, clinical assessments, and regulatory compliance for both investigational and marketed products. This is a hybrid role with significant collaboration across clinical, regulatory, and safety functions.
Key ResponsibilitiesReview, process, and track adverse event reports in compliance with FDA, ICH guidelines, and internal SOPs
Apply clinical judgment to assess, code, and query case data (AEs, medical history, medications)
Draft high-quality, medically-sound safety narratives and queries
Collaborate with internal teams (clinical, regulatory, QA) and external CROs to ensure timely and accurate safety reporting
Perform SAE reconciliation with clinical trial databases (e.g., Trailmaster)
Support the development and review of SOPs and Safety Management Plans
Act as a liaison between the safety team and external partners for case-related communications
Contribute to continuous improvement of pharmacovigilance processes
Clinical degree: PharmD, RPh, BSN, or RN
3 5 years of drug safety or clinical safety experience
At least 2 years of hands-on clinical experience in a medical setting
Strong grasp of medical and pharmacology concepts
Experience handling oncology safety cases
Familiarity with FDA/ICH regulatory safety reporting requirements
Proficient with safety databases: ArisG, Argus, or Clintrace
Solid understanding of clinical trial systems (Trailmaster or similar preferred)
Strong attention to detail and the ability to synthesize complex data
Oncology case processing experience
Experience drafting MedDRA-coded narratives and queries
Exposure to global safety reporting requirements