
Lead the Peer Quality Control (PQC) function for aggregate safety reports, ensuring high-quality, compliant, and timely review of PBRERs, PSURs, PADERs/PAERs, DSURs, CARs, and other regulatory safety documents.
Manage workflow planning, resource allocation, quality metrics, and delivery timelines for a global team supporting regulatory submissions.
Serve as the Subject Matter Expert (SME) for PQC processes, quality standards, training, QDoC systems, and regulatory compliance requirements.
Lead, coach, mentor, and develop PQC analysts through performance management, succession planning, career development discussions, and skill-building initiatives.
Drive continuous improvement, automation, AI adoption, dashboard enhancements, and Lean Six Sigma initiatives to improve quality, efficiency, and operational excellence.
Partner with global stakeholders, document authors, vendors, and cross-functional teams to resolve quality observations and ensure regulatory readiness.
Support regulatory inspections, internal audits, compliance activities, SOP implementation, and training curriculum governance.
Monitor vendor quality performance, analyze error trends and quality metrics, and implement corrective and preventive actions to enhance inspection readiness.
Contribute to strategic initiatives, process enhancements, and digital transformation efforts, including QDoC system improvements and AI-enabled solutions.
Performed independent quality reviews of aggregate safety reports including PBRERs, PSURs, PADERs/PAERs, DSUR and CARs to ensure regulatory compliance, accuracy, consistency and completeness.
Manage Peer Quality controld activities, including actively reviewing team assiggnments, compliance tracking, quality metrics and timeliness reporting.
Participated in special projects and process improvement initiatives and workflow optimization activities.
Worked closely with global report authors and stakeholders across the US, Europe, Philippines and India to ensure consistent quality standards.
Reviewed and ensured quality of ICSRs, supported pharmacovigilance compliance and drove quality excellence in case processing operations.
Database used: ARISG, SCEPTRE & PV247.
Participate in review of activities, devising and establishing company's quality procedures, standars and specifications.
Conducting internal audit a regualr intervals and participating in the third party audit/client audit.
Manage the company audit schedule and support HOD for management of audit program and vendor audits including, hosting and follow upof system audits.
Maintained permanent organized document record of all sefety reports received and reprorted.
Review of employees training needs at regular basis and organize internal and external training sessions as required.
Provide subject matter expertis to acquisition consulting projects, ensurign excellence in technical performance.
Track significant changes of the drug development process from lead through early pre-clinical study and clinical phases until it is launched or discontinued and beyond to give a complete picture of competitors' clinical programs by analyzing and investigating what is behind the raw information.
Managed a team of 15 members at the time of departure.
Integrated R & D Excellence Green Belt for DMAIC Project - PFizer
Lead a global Peer Quality Control team responsible for quality review of aggregate pharmacovigilance reports, people leadership, compliance oversight, process optimization, AI-driven innovation, and continuous improvement initiatives supporting regulatory submissions worldwide.