Senior Clinical Research Specialist
Medtronic
- Specialty: Other
- Job type: Full-time
- Salary: $100,000 – $150,000
- License states: Any US
Provides operational leadership for end-to-end intake and triage processes for Individual Case Safety Reports (ICSRs) across global Lilly and vendor operations. Ensures timely, accurate, and compliant receipt, acknowledgment, and initial assessment of adverse event information from all sources globally. Leads global operations for case intake from spontaneous reports, clinical trials, literature, digital/social media, regulatory authorities, business partners, and patients/consumers. Oversees global triage processes ensuring accurate case classification, prioritization, and routing based on regulatory timelines and medical urgency. Manages acknowledgment of receipt processes ensuring compliance with regulatory time frames. Leads invalid case assessment and follow-up activities. Oversees literature screening and case identification processes. Ensures appropriate escalation pathways for serious, unexpected, or urgent safety issues. Maintains oversight of intake performance metrics. Implements continuous improvement initiatives. Supports regulatory inspections and audits. Partners with cross-functional teams. Supervises multiple Manager-level leaders and their teams. Requires Bachelor's degree in nursing, pharmacy, life sciences, or related health sciences field; 5+ years in Pharmacovigilance with at least 3 years focused on case intake/triage operations; 2+ years managing people or leading teams; experience with safety databases.
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