Drug Safety Specialist

Location: Hybrid (Minimum 3 days onsite per week)

Type: Full-Time

Department: Pharmacovigilance

Position Summary

We are seeking a skilled and detail-oriented Drug Safety Specialist to join our team. This role is responsible for processing adverse event reports and supporting pharmacovigilance activities for both investigational and marketed products. The ideal candidate brings strong clinical judgment, regulatory knowledge, and experience in drug safety case management.

Key Responsibilities

Case Processing (50%)

• Manage the end-to-end processing of adverse event reports, including receipt, assessment, documentation, and submission, in compliance with FDA regulations, ICH guidelines, company SOPs, and partner agreements.
• Perform accurate medical coding of events, medical history, and concomitant medications using clinical judgment.
• Ensure timely follow-up and resolution of adverse events, including SAE reconciliation and quality reviews.
• Support ongoing safety surveillance and contribute to identification of events of special interest and aggregate trend analysis.
• Implement continuous quality improvements to maintain high data integrity across projects.

Vendor Management & Coordination (25%)

• Act as the primary liaison between Alkermes and external stakeholders such as CROs, call centers, and investigator sites.
• Collaborate with internal departments including Clinical Operations, Regulatory Affairs, Medical Information, Product Development, QA, Biostatistics, Data Management, and Legal.

Clinical Project Support (25%)

• Participate in cross-functional project teams supporting clinical trials.
• Review and provide feedback on study-related documents, including protocols and safety sections of clinical reports.

Additional Responsibilities

• Assist in the development and maintenance of pharmacovigilance SOPs and study-specific Safety Management Plans.
• Support responses to Health Authority inquiries and provide safety data for regulatory submissions (e.g., IND safety reports, Annual Safety Reports, PSURs, and CSRs).
• Perform other duties as assigned.

Basic Qualifications

• Clinical degree (e.g., PharmD, RPh, BSN, RN)
• 3–5 years of experience in drug safety or clinical safety
• Minimum of 2 years of clinical experience in a healthcare setting
• Demonstrated medical and pharmacological knowledge

Preferred Qualifications

• Experience processing oncology safety cases
• Strong understanding of domestic and international pharmacovigilance regulations (FDA, ICH, GCP)
• Proficient in commercial safety databases (e.g., ArisG, Argus, or Clintrace); familiarity with clinical trial systems such as TrailMaster is a plus
• Ability to analyze clinical data and craft follow-up queries using sound medical reasoning
• Excellent written and verbal communication skills
• Strong organizational, problem-solving, and multitasking abilities
• Proactive, self-directed, and collaborative team player

Work Environment

This is a hybrid position based in our Massachusetts office. A minimum of three days onsite per week is required.