Seethalakshmi Viswanathan
16 Yrs
Chennai, India
2500000.00
Full-Time (40h/week)
Vetted Skills
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Profile Summary
Pharmacovigilance professional with 16 years’ experience in drug safety, ICSR case processing, signal management, and regulatory compliance. Expertise in quality management, team leadership, CAPA, and performance metrics. Skilled in data analysis (SQL, Tableau, Power BI) and LEAN/Six Sigma. Award-winning leader committed to process excellence, compliance, and continuous improvement in PV systems.
Skills & Expertise
Technical Skills
Soft Skills
Professional Details
Pharmacovigilance Manager
Planning and executing daily tasks, ensuring strict adherence to SLA timelines and deliverables, while working by applicable procedure documents, conventions, and client policies. Delegating Safety Review cases by critically appraising the potential of team members. Managing workflow in compliance with KPI, PVA, and regulatory standards. Analyzing troubleshot and providing actionable medical inputs and developing strategic interventions for performance improvement through the evaluation of complex adverse event case reports.
Subject Matter Expert
Provided in-depth knowledge on case processing conventions, intertwined with PV regulations, guidelines, and best practices. Functioned as a consultant to the project teams on PV-related queries and strategic decisions. Addressed complex issues and troubleshot challenging or unprecedented PV issues during the project lifecycle.
Drug Safety Reviewer
Reviewed individual case forms and documents. Encoded verbatim terms using MedDRA for patient history, product indication, and event term information in ARGUS database. Responsible for completing the adverse event case; and sending the updated and related documents or information to Medical Review Physician.
Data Entry/Quality Control
Performed data entry of individual cases in the CARES database. Conducted quality control (QC) of data entry cases and provided timely feedback to the team to improve quality. Ensured consistency with quality, accuracy, and medical safety standards.