Arun Hira

Results-driven professional with expertise in safety databases and regulatory compliance. Proven track record in project leadership and cross-functional collaboration, enhancing operational efficiencies and ensuring timely compliance with global pharmacovigilance requirements.

• Spearheaded DSUR/PSUR/PBRER/CSR submissions with high compliance and client satisfaction.
• Designed and implemented automation workflows for compliance tracking, reducing manual effort by 40%.
• Set up ICSR metric dashboards to track compliance, volume, and resource utilization.
• Successfully managed recruitment & training cycles, scaling teams for high-volume projects.
• Established Drug Information & Poison Information Centers during academic tenure.
• Recognized for strong interpersonal, client-facing, and leadership skills.

Date of Birth: 08/01

• English
• Hindi
• Punjabi

• Taught Pharmacy courses (B. Pharm, Pharm D) aligned with PCI curriculum.
• Engaged in hospital ward rounds for Pharm D training and drug information services.

Comprehensive management of Individual Case Safety Reports (ICSRs): triage, duplicate checks, narrative writing, causality assessment, expectedness evaluation, and company comments., Skilled in MedDRA coding, consistent with 'Points to Consider' guidelines., Experienced in compliance dashboards, safety database reporting, and ERP systems., Hands-on experience with EudraVigilance downloads and case triage., End-to-end knowledge of global regulatory obligations for expedited and periodic safety reporting., Case processing experience across drugs, biologics, medical devices (eMDRF), and vaccines., Led teams for DSUR, PSUR, PBRER, CSR, ASR, and SUSAR reporting., Recruitment & onboarding: coordinated new hire selection, recurrent hiring cycles, and affiliate onboarding., Designed job role matrices and capacity calculation models to balance workload against forecasted case volumes., Supervised team KPIs, compliance metrics, and quality outcomes with data-driven dashboards., Acted as primary client contact for operational and compliance discussions., Conducted RCA & CAPA analysis for quality deviations and late submissions., Project Setup & Transition: Defined workflows, safety database configuration, role responsibilities, and governance models during client onboarding and offboarding., Audit & Inspection Readiness: Successfully supported internal/external audits and HA inspections with zero critical findings., Process Automation: Implemented tools to automate compliance tracking, late case alerts, and quality dashboards, enhancing team efficiency., ICSR Metrics & Forecasting: Developed and monitored case processing metrics (volume, productivity, quality, compliance) to support capacity/resource planning., Workforce Planning: Designed hiring and training plans based on historical workload, case volume projections, and KPI performance trends., Experienced in BCP & Pandemic Planning, ensuring operational continuity during global disruptions., QC/QA of ICSRs and periodic reports ensuring adherence to HA requirements., Managed lateness documentation forms (LDFs) as per partner and regulatory requirements., Applied Six Sigma principles in process improvement initiatives., Automated compliance & efficiency tracking workflows., Trained PV Scientists in ICSR processing, MedDRA coding, GVP modules, and regulatory compliance., Mentored new hires; recognized as a client-certified trainer for global affiliate onboarding., Conducted SOP/Work Instruction trainings aligned with project-specific requirements.

• Registered Pharmacist