About
Highly accomplished Pharmacovigilance Specialist with 7+ years of comprehensive experience in global drug safety, post-marketing surveillance, and clinical trial pharmacovigilance. Expertly manages end-to-end ICSR processes, E2B partner case intake, and regulatory reporting, consistently ensuring data integrity, compliance, and inspection readiness across multinational pharmaceutical environments. Proven leader in driving process improvements, mentoring teams, and delivering high-quality pharmacovigilance operations that meet stringent global regulatory standards.
Work
CONTINUUM INDIA LLP
|PHARMACOVIGILANCE SPECIALIST
Chandigarh, India, India
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Summary
Leading end-to-end processing of oncology clinical trial safety cases, managing intake, assessment, and regulatory submissions within global pharmacovigilance operations.
Highlights
Directed end-to-end processing of oncology clinical trial safety cases from intake through regulatory submission, ensuring compliance with global standards.
Managed comprehensive case lifecycle activities, including intake, processing, quality review, and distribution within Argus Safety, optimizing workflow efficiency.
Developed and presented monthly dashboards detailing KPIs, case volumes, quality metrics, and compliance status, providing actionable insights for management.
Served as Project Manager backup and provided onsite pharmacovigilance support at a U.S.-based pharmaceutical client, enhancing operational continuity and local efficiency.
Contributed significantly to inspection readiness initiatives and internal audit preparations, bolstering organizational compliance and quality assurance.
Ensured robust data integrity and consistency across Argus Safety Database and EDC systems, minimizing discrepancies and enhancing reporting accuracy.
CONTINUUM INDIA LLP
|PHARMACOVIGILANCE ANALYST
Chandigarh, India, India
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Summary
Processed post-marketing Individual Case Safety Reports (ICSRs) and E2B reports, ensuring regulatory compliance and data quality for global license partners.
Highlights
Processed post-marketing Individual Case Safety Reports (ICSRs) and E2B reports in Argus Safety, ensuring accurate data entry and regulatory compliance.
Executed meticulous data entry, quality review, and compliance checks for adverse event reports, maintaining high data integrity standards.
Mentored newly hired team members, providing comprehensive training and operational support to enhance team performance and efficiency.
Conducted trend analysis of processing errors and delivered targeted quality improvement training sessions, enhancing team accuracy and compliance.
Tracked key performance indicators (KPIs) and generated detailed operational reports for management, supporting data-driven decision-making.
Collaborated with Argus technical support teams to investigate and resolve system-related issues, minimizing downtime and maintaining system functionality.
PAREXEL INTERNATIONAL
|DRUG SAFETY ASSOCIATE
Chandigarh, India, India
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Summary
Managed ICSR intake activities for over 50 global pharmaceutical affiliates, performed regulatory submissions, and supported data quality and process improvements.
Highlights
Managed ICSR intake activities for over 50 global pharmaceutical affiliates, ensuring efficient and compliant case reception and processing.
Executed timely regulatory submissions to Health Canada (MHPD) and other health authorities, maintaining strict compliance with national guidelines.
Processed adverse event reports efficiently within the Argus Safety Database, ensuring data accuracy and completeness for critical safety assessments.
Conducted thorough reconciliation activities across safety databases, vendors, and partner organizations, ensuring data consistency and integrity.
Mentored new team members on pharmacovigilance processes and workflows, contributing to team skill development and operational readiness.
Supported the implementation of automated case book-in processes via intake portals and ARTEMIS systems, improving processing efficiency by streamlining data capture.
Education
Chaudhary Charan Singh University
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Bachelors of Dental Surgery (BDS)
Dental Surgery
Languages
English
Skills
Safety Systems
Oracle Argus Safety, ARTEMIS, OBIEE, iTracker, EDC Systems.
Pharmacovigilance
End-to-End ICSR Processing, Clinical Trial Safety, Post-Marketing Surveillance, E2B Intake, Selective Acceptance, Follow-up Management, Regulatory Reporting, Bulk Reporting, ICSR Bulk Transmission, Audit Log Review, Reconciliation Activities, Data Integrity Verification.
Reporting & Analytics
KPI Tracking, Trend Analysis, Operational Reporting, Compliance Monitoring, Root Cause Analysis.
Microsoft Office
Excel, PowerPoint, Word.