01Overview
Job title- ICSR Submissions Specialist (Pharmacovigilance)Reports to-VP Operations Job purpose The ICSR Submission Specialist (Pharmacovigilance) will be responsible to ensure the accurate, compliant, and timely submission of Individual Case Safety Reports (ICSRs) to global regulatory authorities by managing end-to-end case submission activities. The role safeguards regulatory compliance and uninterrupted pharmacovigilance reporting operations through effective handling of expedited and periodic safety reports, resolution of technical transmission issues, and maintenance of inspection-ready documentation. By collaborating cross-functionally with Case Processing, QA, IT, and Regulatory teams, the specialist supports global drug safety obligations and contributes to the integrity of patient safety data.Duties and responsibilities Manage endtoend ICSR submissions to global regulatory authorities (e.g., FDA, EMA, MHRA, PMDA, Health Canada) in compliance with regional and global reporting requirements.Ensure timely submission of expedited (7day, 15day) and nonexpedited cases, including followups, in accordance with regulatory timelines and internal SOPs.Perform E2B(R2/R3) electronic submissions via regulatory gateways, ensuring successful transmission, acknowledgements, and resolution of technical errors.Monitor and track submission status, acknowledgements, and agency responses; proactively investigate and resolve submission failures or rejections.Conduct quality and compliance checks on ICSRs prior to submission to ensure data completeness, accuracy, and regulatory acceptability.Collaborate closely with Case Processing, QA, IT, and Regulatory Affairs teams to support uninterrupted submission operations and address data or system issues.Maintain submission logs, reconciliation records, and compliance metrics to support inspections, audits, and management reporting.Serve as a subjectmatter expert (SME) for ICSR submission processes, regulatory requirements, and system functionalities.Support regulatory inspections, audits, and health authority queries, providing submission evidence and compliance documentation as required.Ensure adherence to global safety reporting standards, including ICH E2B, ICH E2A, and applicable GVP/21 CFR requirements.Identify opportunities for process improvement and automation, contributing to increased efficiency and reduced submission errors.Provide training and guidance to junior team members on submission procedures, regulatory expectations, and system usage.Qualifications Bachelors or masters degree in pharmacy, Life Sciences, or Medicine5 years of experience in PharmacovigilanceMinimum 3 years of handson experience in ICSR submissionsStrong knowledge of ICH E2B (R2/R3), global ICSR reporting timelines, and regional regulatory requirementsProficient in Argus Safety (mandatory), E2B gateways, and regulatory portalsExpert in supporting global submissions across EU, US, and Rest of WorldProficient in partner safety data exchange agreementsMandatory exposure to signal management & aggregate reportingProven background in CRO & pharmaceutical environmentsWorking conditions This position is fully officebased (onsite).Job may require availability beyond standard working hours to support priority business needs, audits, or inspections.Physical requirements This is a largely sedentary role.Direct Reports N/A .
