PANKAJ KALIA

· Conducted QC/QA of ICSRs ensuring compliance with internal/external and regulatory standards.

· Maintained Client-specific quality metrics and performed data trend analysis.

· Reported QC/QA issues, mentored new Quality Scientists, and supported audits and inspections.

· Handled regulatory report submissions and supported systems including VEEVA RIM, VAULT, and EMA tools.

· Analyzed in-process quality checks, tracked findings, and implemented actions from global PV leads.

· Oversaw CAPA management, root cause analysis, and effectiveness checks for quality deviations.

· Led case quality review meetings and communicated analysis results to PV community.

· Managed ICSRs of all case types and performed quality reviews including source document checks

· Ensured KPIs compliance and supported audits, inspections, and training documentation updates.

· Conducted case reconciliation and adverse event follow-ups using ARGUS, AWARE, and OBIEE tools.

· Managed client-related activities as Process Owner and developed performance improvement strategies.

· Prepared team communications and supported tight deadlines in a fast-paced environment.

· Handled shared mailboxes, reconciliations, and ICSR submissions

· Coordinated team meetings and liaised with clients for process improvements.

· Managed all ICSR case types including triage, data entry, validation, and medical review.

· Performed duplicate searches, expectedness assessments, and ensured GVP compliance.

• Company Overview: Shiva Dental Clinic provides various dental services and patient care.
• Performed root canal procedures and managed pain effectively.
• Educated patients about dental care and created treatment plans.
• Conducted thorough patient examinations and screenings for oral issues.
• Administered care in emergency situations and diagnosed oral diseases.
• Shiva Dental Clinic provides various dental services and patient care.