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.
The role includes SAE reconciliation, meeting compliance and productivity targets, and supporting onboarding and training for new team members.
Key Responsibilities: 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.
SAE Reconciliation: Perform SAE reconciliations between safety and clinical databases, track progress, resolve issues, and escalate when necessary.
Quality & Compliance: Adhere to KPI and quality metrics, ensuring productivity and process improvement within ICSR management.
Decision-Making: Execute decisions in line with operational policies, SOPs, and work instructions.
Vendor/CRO Coordination: Ensure ICSR activities align with PV agreements and contracts.
Training & Onboarding: Develop and update training materials, onboard new team members, provide feedback, and support the onboarding process.
Qualifications: Bachelor's degree in life sciences, clinical medicine, nursing, pharmacy, or equivalent experience; advanced degree preferred.
Proficiency with Argus safety database and MS Office Suite.
Minimum 2 years of experience in drug safety/pharmacovigilance or relevant clinical experience.
Preferred 5-8 years of experience Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA, MHRA) for pharmacovigilance reporting.
Excellent communication, problem-solving, time management, and attention to detail.
Global cultural awareness and collaborative mindset.