Job Description

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.

• Review, 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

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