Minija Mohandas

Pharmacovigilance professional with over 9 years of experience in drug safety operations, clinical trial safety, regulatory compliance, quality review, signal detection, aggregate reporting and risk management across global clinical research environments. Proven expertise in safety case management, SAE reconciliation, regulatory reporting, and stakeholder collaboration. Skilled in Argus Safety, Veeva Vault, and clinical data systems, with a strong track record of driving quality, compliance, and operational excellence.

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

Managed end-to-end safety event intake, investigation, documentation, and reporting activities while ensuring compliance with global regulatory requirements.

• Conducted aggregate safety reporting, including preparation of DSURs for clinical trials, and performed safety signal detection, evaluation, and trend analysis to support ongoing benefit-risk assessment.
• Supported compliance monitoring activities through review of quality metrics, trend analysis, and issue escalation to ensure adherence to pharmacovigilance procedures.
• Contributed to CAPA activities by supporting root cause investigations, implementation tracking, and effectiveness verification for identified quality issues.
• Assisted audit and inspection readiness activities through documentation review, evidence preparation, and follow-up of compliance actions.
• Authored Safety Management Plans and contributed to quality and compliance initiatives supporting inspection readiness.
• Served as SME for Veeva Vault, Medidata Rave, and Medrio platforms while supporting training and process standardization initiatives.

Operations Specialist I / Drug Safety Associate/ Drug Safety Associate Trainee at IQVIA (2016-11 – 2019-04)

Reviewed and processed safety complaints and adverse event reports in accordance with regulatory requirements and company procedures.

• Performed quality checks and data verification activities to ensure accuracy and completeness of safety information.
• Investigated case discrepancies and collaborated with internal stakeholders for timely resolution.
• Supported reconciliation and compliance monitoring activities across multiple clinical programs.
• Contributed to continuous improvement initiatives focused on quality, productivity, and compliance.
• Managed high-volume case processing while maintaining quality standards and regulatory timelines.

Bachelor of Engineering (B.E.) in Biomedical Engineering – Rajalakshmi Engineering College, Anna University, Chennai (2011-08 – 2015-05)