Chaithra P

ICSR Operations and Sponsor Quality Check

• Performed Sponsor Quality Check (SQC) on sample of ICSRs processed by vendors on daily basis to ensure completeness, accuracy, and compliance with global regulations.
• Answer and resolve case-related quality queries raised by case processing vendors.
• Review and approve expedited and non-expedited ICSRs as per global regulatory timelines.
• Conduct quality trend analysis and prepare sponsor quality analysis reports for internal compliance meetings and monthly governance discussions.
• Reviewing the global device and combination product Individual Case Safety Report (ICSR) for both Clinical trial and post-marketing cases.
• Providing high quality device and combination product case processing through defined global regulatory authority standards.
• Providing internal trainings with procedural guidance, and resources necessary to execute delegated pharmacovigilance and safety case management activities in a compliant and timely manner.
• Provide support for audits and regulatory inspections related to case management activities, including coordination with vendors to ensure documentation accuracy, completeness, and inspection readiness.
• Perform activities delegated by the Qualified Person for Pharmacovigilance (QPPV), as defined in the Pharmacovigilance System Master File (PSMF), and maintain a continuous state of inspection readiness.
• Execute additional responsibilities in accordance with approved Standard Operating Procedures (SOPs) and as assigned by management.
• Reviewing all device related coding before approval for compliance.

Vendor & Compliance Overnight

• Monitor vendor case intake processing quality, SLAs, and regulatory compliance.
• Identify quality gaps and implement CAPAs in coordination with stakeholders.
• Escalate system quality concerns and recommend process improvements.

Product & Labelling Support

• Conduct labelling/expectedness assessments using Reference Safety Information (RSI).
• Identify company suspect drugs based on country approval status and product labeling.
• Support maintenance of product dictionaries and alignment with regulatory updates.

Cross-Functional Collaboration

• Liaise with Business partners, QA, and Global affiliates for safety data compilation and reporting.
• Support Safety Data Exchange Agreements (SDEA) compliance and reporting obligations.

Audit and Inspection Readiness

• Act as Subject Matter Expert (SME) for AE handling during audits and regulatory inspections.
• Maintain inspection-ready documentation aligned with PV System Master file (PSMF).
• Support Health Authority Inspections (FDA/ EMA) and internal audits.

• Monitored and reported quality metrics as case triager, ensuring compliance with regulatory standards.
• Reviewed data in safety database for accuracy and completeness.
• Identified and resolved duplicate records in safety database, safeguarding data integrity. and registered cases in safety database.
• Determined validity of cases and completed triage processes efficiently.
• Delivered constructive feedback to team members, fostering skill development.
• Maintained log of source documents and communications for reference.
• Provided guidance for data entry and quality teams to enhance accuracy.
• Followed up with sites regarding outstanding queries and reconciliation discrepancies.
• Oversaw activities of drug safety associates, ensuring adherence to departmental procedures.
• Trained and mentored new team members to enhance onboarding and ensure alignment with project requirements.
• Identified and resolved issues within the project team to maintain productivity.
• Delegated tasks to personnel, improving workflow efficiency and project execution.

• End-to-end case processing (data entry, coding, narrative writing) in ARGUS and ARISg databases.
• Managed solicited and unsolicited cases to meet global regulatory timelines and ensure timely reporting.
• Conduct labelling/expectedness assessments using Reference Safety Information (RSI).
• Ensured compliance with SOPs & AE workflow procedures.