Description The Drug Safety Associate provides operational and documentation support for the company’s clinical safety and pharmacovigilance activities. Working closely with the Drug Safety Manager, this role helps ensure timely, accurate, and compliant safety oversight across multiple studies managed by CRO partners. Essential Duties and Responsibilities The main responsibilities of this role include: Track safety case flow, status, and reporting activities across clinical studies using sponsor and CRO tools. Review and quality check safety data outputs for completeness, consistency, and alignment with study expectations. Support reconciliation between clinical and safety databases, including documenting checks and resolutions. Maintain safety logs, trackers, training records, deviation records, action items, and related documentation. Coordinate collection, version control, and filing of safety documents in the TMF and safety system files. Organize and document safety review meetings, including agendas, minutes, attendance, and follow-up items. Coordinate with CROs, vendors, and internal stakeholders on safety meetings, deliverables, timelines, and escalations. Maintain safety contact lists, distribution lists, routing instructions, templates, checklists, and forms. Support audit and inspection readiness by assembling documentation packages and evidence of oversight. Assist with implementation and documentation of CAPAs related to safety processes. Prepare slides, summaries, and other administrative materials to support Safety and clinical teams. Other duties as assigned. Education and Experience BA degree in Nursing, Pharmacy, Public Health, Biomedical Sciences, Life Sciences, or a related healthcare or scientific discipline. Clinical credential or healthcare certification, such as RN, PharmD, PA, or equivalent, preferred. Minimum of 1–3 years of relevant experience in clinical research, drug safety/pharmacovigilance, clinical trial coordination, clinical data management, or a related function within a biotechnology, pharmaceutical, or CRO environment. Knowledge and Skills Working knowledge of clinical trial operations and safety reporting concepts, including SAE, SUSAR, MedDRA, and ICH GCP, with the ability and interest to further develop pharmacovigilance expertise. Strong attention to detail, accuracy, and organization, with the ability to manage multiple trackers, documents, timelines, and study-related deadlines simultaneously. Proficiency with Microsoft Office Suite, including Excel, PowerPoint, Word, and Outlook, as well as file-sharing platforms, online meeting tools, and the ability to quickly learn new systems, dashboards, and workflows. Effective written and verbal communication skills with the ability to collaborate cross-functionally in a small, fast-paced team environment. Prior experience supporting drug safety or pharmacovigilance operations, including case tracking, TMF filing, safety meeting coordination, and collaboration with CRO partners. Experience working in an early-stage biotechnology company or similarly dynamic, growth-oriented environment.
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