PRAGADEESH MANIGANDAN

Assistant Manager, Pharmacovigilance

Dublin, IE.

About

Highly accomplished Pharmacovigilance SME with 8 years of progressive experience in global drug safety, compliance, and risk management. Proven ability to lead end-to-end PV operations, manage regulatory submissions, and ensure inspection readiness while driving continuous improvement and cross-functional collaboration. Seeking to leverage deep expertise in regulatory frameworks and quality systems to optimize drug safety processes and enhance compliance in a dynamic pharmaceutical environment.

Work

Navatio Pharma

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Assistant Manager

Hyderabad, India, India

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Summary

Led comprehensive pharmacovigilance projects, ensuring regulatory compliance and operational excellence in post-marketing surveillance.

Highlights

Directed project planning, resource allocation, and delivery schedules for multiple post-marketing surveillance PV projects, ensuring timely execution and resource optimization.

Served as the primary client liaison for audit readiness and regulatory inspections, facilitating seamless communication and ensuring robust compliance posture.

Managed end-to-end pharmacovigilance operations, optimizing processes for comprehensive drug safety management and reporting.

Developed and implemented robust SOPs, Work Instructions, and compliance frameworks, ensuring alignment with evolving regulatory requirements and industry best practices.

Spearheaded project planning, progress tracking, and issue resolution, consistently achieving successful project outcomes and mitigating potential delays.

Actively contributed to successful internal, external, and regulatory audits by providing comprehensive documentation review and addressing compliance queries.

Scitus Pharma Services

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Lead QC

Chennai, India, India

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Summary

Directed quality control for pharmacovigilance projects, ensuring compliance with client and regulatory guidelines.

Highlights

Ensured effective functioning of all PV projects in compliance with client and regulatory guidelines, proactively mitigating risks and ensuring data integrity.

Conducted comprehensive Root Cause Analysis (RCA) and implemented Corrective and Preventive Actions (CAPA) strategies, effectively resolving audit findings and process deviations.

Monitored and enforced adherence to SOPs, working instructions, and quality metrics, driving continuous process improvement and operational excellence.

Mentored and trained junior staff on safety database operations, narrative writing, and MedDRA coding, enhancing team capabilities and knowledge transfer.

Bioclinica

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Senior Drug Safety Associate

Mysore, India, India

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Summary

Managed quality, workload, compliance, and documentation across pharmacovigilance projects.

Highlights

Managed quality, workload, and compliance across diverse PV projects, enhancing operational efficiency and adherence to regulatory standards.

Processed and reviewed literature cases, ensuring high accuracy in safety data capture and maintaining data quality.

Achieved over 98% quality metrics in data quality reviews and case entry, consistently ensuring high data integrity and compliance.

Accenture Solutions Pvt. Ltd

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Medical Service Analyst

Bangalore, India, India

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Summary

Processed serious and non-serious adverse event reports with an emphasis on quality and compliance.

Highlights

Processed end-to-end serious and non-serious adverse event reports (solicited and unsolicited), ensuring comprehensive and timely documentation.

Maintained accurate and consistent data entry with an emphasis on quality and compliance, upholding high standards of data integrity.

Education

JSS College of Pharmacy

Ooty, India, India
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Doctor of Pharmacy Pharmacy

Skills

Audit & Quality Management

Regulatory Audit Readiness, Internal Audit Readiness, CAPA, Root Cause Analysis (RCA), Process Improvement, SOP Development, Work Instruction (WI) Development, Quality Management Systems.

Pharmacovigilance Operations

PV Operations Management, Case Processing, Drug Safety Operations, Literature Surveillance, Signal Detection, Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), MedDRA Coding, Narrative Writing.

Regulatory Affairs & Compliance

QPPV Support, Regulatory Compliance, Pharmacovigilance Regulations, Good Pharmacovigilance Practice (GVP), ICH Guidelines, MICC, PV Regulatory Frameworks.

PV Databases & Software

Argus, ArisG, Clienvo, PV Edge.

Project & Team Management

Project Planning, Resource Allocation, Delivery Scheduling, Client Communication, Issue Resolution, Progress Tracking, Team Mentorship, Time Management.