Drug Safety Associate

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 ResponsibilitiesThe 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.