Senior Specialist, Global Icsr

Senior Specialist, Global Icsr - Detalhes da Vaga. ● 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:Bachelors 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 experienceStrong 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. ●. Requisitos para participar do processo. ● . O que oferecemos.