Senior Global Case Manager, (ICSR Case Processing)
Title: Senior Specialist, Global ICSR Case Processing & QC
Department: Global Patient Safety
Overview: Seeking an experienced Senior Specialist in Global ICSR Case Processing & QC to independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory compliance and excellence in data accuracy, completeness, and quality.
Key Responsibilities:
1. ICSR Case Processing: Manage case processing and quality control of ICSRs from diverse sources (e.g., clinical trials, post-market, literature) to ensure timely, accurate submissions to regulatory authorities.
2. SAE Reconciliation: Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and escalate when necessary.
3. Quality & Compliance: Adhere to KPI and quality metrics, ensuring productivity and process improvement within ICSR management.
4. Decision-Making: Execute decisions in line with operational policies, SOPs, and work instructions.
5. Vendor/CRO Coordination: Ensure ICSR activities align with PV agreements and contracts.
6. Training & Onboarding: Develop and update training materials, onboard new team members, provide feedback, and support the onboarding process.
Qualifications:
1. Bachelor’s degree in life sciences, clinical medicine, nursing, pharmacy, or equivalent experience; advanced degree preferred.
2. Proficiency with Argus safety database and MS Office Suite.
3. Minimum 2 years of experience in drug safety/pharmacovigilance or relevant clinical experience; preferred 5-8 years of experience.
4. Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA, MHRA) for pharmacovigilance reporting.
5. Excellent communication, problem-solving, time management, and attention to detail.
6. Global cultural awareness and collaborative mindset.
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