Minija Mohandas

Dynamic and award-winning professional with experience leading global drug safety operations, quality compliance programmes, regulatory reporting, and governance initiatives across various environments. Track record in managing safety operations, complex safety data, and regulatory submissions while maintaining compliance with ICH-GCP requirements and quality standards. Strong expertise in audit and inspection readiness, including documentation governance, compliance assessments, evidence management, and cross-functional stakeholder coordination.

Skilled in developing compliance metrics, monitoring performance indicators, analysing safety trends, driving root-cause analysis and CAPA execution, and delivering actionable insights for risk mitigation and data-driven decisions. Recognised for optimising pharmacovigilance systems through process improvement, metrics governance, and workflow standardisation that enhance efficiency, compliance, and patient safety outcomes.

Pharmacovigilance Operations Specialist III / II / Specialist at CAIDYA (2019-06 – 2026-04)

Directed pharmacovigilance operations across global clinical and post-marketing programmes, managing approx. 90 safety cases monthly while supporting regulatory compliance, safety surveillance, and database integrity. Oversaw adverse event management, regulatory reporting, quality oversight, and inspection readiness while driving process improvements, system optimisation, and operational consistency across multiple studies and safety platforms. Strengthened team capability through onboarding support, mentoring, knowledge-sharing initiatives, and continuous process improvement activities.

• Eliminated 250+ legacy safety case backlog by restructuring workflow, optimising resource allocation, and implementing daily task distribution, achieving completion ahead of the deadline without disrupting ongoing case processing.
• Designed a centralised cloud-based safety intake tracking system for SAE email reporting, improving visibility, reducing case intake misses by 98%, and achieving 100% regulatory compliance through monitoring and accountability controls.
• Designed and implemented a structured quality review checklist with integrated feedback tracking, enabling systematic error identification and improving case quality performance by 40%.
• Managed end-to-end pharmacovigilance activities encompassing case intake, investigation, follow-up coordination, narrative support, and expedited reporting across global programmes.
• Advanced signal detection efforts through safety data analysis, trend identification, and escalation of emerging risks to support timely evaluation and informed decision-making.
• Achieved 98% compliance performance by strengthening quality monitoring, leading root-cause investigations, supporting CAPA implementation, and validating preventive controls.
• Standardised safety documentation by authoring and maintaining safety management plans, work instructions, and procedural guidance that improved consistency across projects.
• Served as subject matter expert for Veeva Vault, Medidata Rave, and Medrio, providing technical guidance, resolving system-related issues, and promoting efficient platform utilisation.

Operations Specialist I / Drug Safety Associate / Drug Safety Associate Trainee at IQVIA (2016-11 – 2019-05)

Conducted high-volume pharmacovigilance activities supporting clinical trial and post-marketing programmes, delivering accurate safety data management, regulatory reporting, and quality oversight in line with global regulations and client requirements. Built a strong record of productivity, accuracy, and compliance while managing complex adverse event workloads within fast-paced operational environments. Supported narrative development, case reconciliation, expedited reporting, and submission preparation for clinical and post-marketing safety programmes.

• Earned multiple performance awards for outstanding productivity and quality, consistently surpassing operational targets and clearing case backlogs ahead of established deadlines.
• Processed adverse event and serious adverse event reports, performing data entry, MedDRA coding validation, follow-up tracking, documentation review, and ICSR lifecycle management.
• Conducted quality control reviews, discrepancy investigations, and compliance assessments to maintain adherence to regulatory requirements, SOPs, and project-specific guidelines.
• Collaborated with clinical teams, safety physicians, and external stakeholders to resolve queries, facilitate information exchange, and support regulatory deliverables.
• Exceeded productivity and quality benchmarks while managing high workloads and meeting critical reporting timelines.

Bachelor of Engineering (B.E.) in Biomedical Engineering – Rajalakshmi Engineering College, Anna University