Drug Safety Associate

The Drug Safety Associate provides operational and documentation support for clinical safety and pharmacovigilance activities. Working with the Drug Safety Manager, the role ensures timely, accurate, and compliant safety oversight across multiple studies managed by CRO partners.

Essential Duties and Responsibilities:
- 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, 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 (agendas, minutes, attendance, follow-up items).
- Coordinate with CROs, vendors, and internal stakeholders on safety meetings, deliverables, timelines, and escalations.
- Maintain safety contact lists and distribution/routing information, 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 administrative materials to support Safety and clinical teams.
- Other duties as assigned.

Requirements:
- BA in Nursing, Pharmacy, Public Health, Biomedical Sciences, Life Sciences, or related discipline.
- Clinical credential/certification (RN, PharmD, PA, or equivalent) preferred.
- 1–3 years’ relevant experience in clinical research, drug safety/pharmacovigilance, clinical trial coordination, or clinical data management.

Knowledge and Skills:
- Working knowledge of safety reporting concepts (SAE, SUSAR, MedDRA) and ICH GCP; interest in developing pharmacovigilance expertise.
- Strong attention to detail and organization; ability to manage multiple trackers, documents, timelines, and deadlines.
- Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word, Outlook) and online/file-sharing tools.
- Effective written and verbal communication; cross-functional collaboration.
- Prior drug safety/pharmacovigilance operations experience (case tracking, TMF filing, safety meeting coordination) preferred.
- Experience in an early-stage biotechnology or similarly dynamic environment.

Salary Description:
- $77,000.00–$90,000.00 annual salary.