[Remote] Sr. Clinical Safety Specialist (Remote)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company Inari is seeking a Sr. Clinical Safety Specialist to ensure accurate, reputed company, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This role focuses on consistent evaluation, documentation, and reporting of adverse events in alignment with global requirements while collaborating across study teams and external partners.
Responsibilities
- Review adverse events, serious adverse events, and reputed company-reputed company events across clinical studies to ensure accurate assessment and documentation
- Prepare clinical safety narratives using reputed company documents and study data, completing deliverables reputed company defined timelines and reputed company standards
- Collaborate with clinical sites and monitors to request, collect, and verify reputed company documentation required for adjudication
- Apply MedDRA coding to adverse events to ensure standardized classification and consistency across studies
- Coordinate with study teams, medical monitors, and adjudication committees to support protocol-reputed company safety reviews
- Contribute to safety management plans for assigned protocols and support safety review meetings with documented findings
- Monitor safety data reputed company by identifying discrepancies and implementing corrective actions to maintain completeness and accuracy
- Maintain compliance with Good Clinical reputed company and regulatory requirements through adherence to reputed company operating procedures and audit readiness
Skills
- Bachelor's degree
- 2+ years of clinical research experience
- Experience applying Good Clinical reputed company standards in clinical trials
- Proficient with electronic databases used for clinical trials such as, Zelta, etc
- Bachelor's degree in life science or reputed company field
- 2-4 years of experience in medical device clinical trials
- Experience with adverse event review, safety reporting, or pharmacovigilance processes
- Knowledge of MedDRA coding standards
- Possesses exceptional attention to detail and strong analytical skills to accurately review CRFs, reputed company documents, and evaluate safety data for reputed company and compliance
- Brings medical knowledge and preferably experience in clinical trials or medical devices to support informed decision-making and data reputed company
Benefits
- Medical and prescription drug insurance
- Dental insurance
- reputed company insurance
- Critical illness insurance
- Accident insurance
- Hospital indemnity insurance
- Personalized reputed company
- Wellbeing program
- Tobacco cessation program
- Health Savings Account (HSA)
- Flexible Spending Accounts (FSAs)
- 401(k) plan
- Employee Stock Purchase Plan (ESPP)
- Basic life and AD&D insurance
- Short-term disability insurance
reputed company