ICSRs Project Lead

Key Responsibilities :

• Perform as the ICSRs Project Lead for assigned pharmacovigilance projects.
• Oversee the receipt and processing of all adverse event reports, whether from spontaneous sources or clinical trials.
• Maintain knowledge of client-specific database conventions.
• Collaborate with internal or external partners for safety database reconciliation.
• Monitor workflow for assigned studies or programs to meet deadlines.
• Draft, modify, and deliver safety presentations to both external and internal stakeholders.
• Assist in developing departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
• Ensure ICSR regulatory submissions are compliant with both US and international regulatory reporting requirements.
• Understand the scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
• Experience in case processing using Argus and handling various types of cases (solicited, literature, spontaneous).
• Generate monthly status reports and other project-specific reports, ensuring data quality and accuracy.
• Conduct quality checks on case data and finalize case versions.
• Manage case follow-ups, including generating queries and clarifications as needed.
• Handle case amendments or deletions and investigate late cases to propose corrective and preventive actions.
• Support data reconciliation, replenishment, and clean-up activities.
• Assist with safety database updates and data migration projects.
• Identify, investigate, and resolve process or training issues, creating corrective / preventive actions (CAPAs) as necessary.
• Participate actively in project team and client meetings, and liaise with clients as appropriate.
• Prepare for and participate in internal, client, or regulatory audits, and support other functional safety leads in audit preparation.

Education and Experience :

Skills Required

Pharmacovigilance, Adverse Event Reporting, Case Processing