Advanced Pharmacovigilance Professional

1 week ago

Hyderabad Secunderabad Telangana, India beBeeICSRs Full time ₹ 15,00,000 - ₹ 28,00,000
ICSRs Project Manager

Our team seeks a skilled and experienced ICSRs Project Manager to oversee the receipt and processing of adverse event reports from various sources. The successful candidate will maintain thorough understanding of client-specific database conventions and support reconciliation with internal or external partners as needed.

Responsibilities:
  • 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.
Requirements:
  • 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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