ICSRs Project Lead

3 weeks ago

Hyderabad, Telangana, India Thepharmadaily Full time
Job Description

- 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.

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