ICSRs Project Lead - Pharmacovigilance

• Project Leadership: Serve as the ICSRs Project Lead for post-marketing pharmacovigilance projects, adhering to client contracts and applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Adverse Event Management: Oversee the receipt and processing of all adverse event reports from various sources, including spontaneous reports and clinical trials, for assigned projects.
• Database Management: Maintain a thorough understanding of client-specific database conventions and support reconciliation with internal or external partners as needed.
• Workflow Monitoring: Support workflow monitoring to ensure project deadlines are met.
• Safety Presentations: Draft, modify, and deliver safety presentations to both external and internal stakeholders.
• SOP and WI Development: Assist in creating and updating departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
• Regulatory Compliance: Ensure compliance with ICSR regulatory submission requirements according to US and international regulations, SOPs, and safety processing guidelines.
• Scheduling Reports: Manage automated and manual scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
• Case Processing: Handle case processing in Argus, including solicited, literature, and spontaneous cases.
• Reporting: Generate monthly status and project-specific reports, ensuring the quality and accuracy of metrics and data.
• Quality Checks: Perform quality checks on case data and finalize case versions.
• Follow-Up and Amendments: Conduct case follow-ups, generate queries and clarifications, and perform case amendments or deletions as needed.
• Investigation and CAPAs: Conduct late case investigations, propose corrective and preventive actions (CAPAs), and support process/training remediation.
• Data Clean-Up: Support reconciliation, replenishment, and data clean-up activities.
• Safety Database Updates: Assist with safety database updates and data migration activities.
• Process Improvement: Investigate and address process or training issues, facilitating the creation of CAPAs and supporting remediation efforts.
• Client and Team Liaison: Actively participate in project team and client meetings, liaise with clients as appropriate, and prepare for internal, client, or regulatory audits.

Education and Experience:

• Master s Degree in Pharmacy (M.Pharm) or Doctor of Pharmacy (Pharm D).
• Minimum of 10 years of experience in pharmacovigilance and safety.