ICSRs Project Lead - Pharmacovigilance Thepharmadaily

10.0 - 12.0 years

8 - 13 Lacs

Hyderabad, Telangana, India

On-site

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.

Posted 2 days ago

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