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.