Senior Pharmacovigilance ConsultantOver 7 years of experience in Pharmacovigilance and Quality Management
Good experience in conducting GVP audits.
Expertise in drafting, reviewing, editing procedural documents, articles and White papers.
Strong working experience in triaging (case processing) and management of ICSR, regulatory submissions to Health Canada, USFDA, TGA, and other bodies.
Highly skilled in MedDRA coding, narrative writing, and medical review (Naranjo Scale of Assessment, WHO probability scale).
Proficiency in safety databases like ARGUS, Aris G, AB Cube-Safety Easy, PV 247, etc.
Solid knowledge of Health Canada (GUI 0102, GUI 0001)/ US FDA/ EMA/TGA/ ISO/ ICH regulations and guidelines for Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP).
Well versed with Good Documentation Practices (GDP).
Strong working experience of aggregate reports (PSUR/ PBRER, PADER, DSUR etc.) and awareness of product lists & requirements for periodic reporting for country products.
Good understanding of Literature search, signal detection & evaluation, risk management, and quality assurance processes.
Well versed with QMS functions like reconciliation of cases from the worklist, tracking of cases based on priority listing (ARGUS), identifying deviation, and preparation of non-compliance report.
Well versed with Microsoft Office Applications (Word, Excel: PIVOT Table, PIVOT Chart, Conditional Formatting, etc., PowerPoint and Outlook) and the Internet.
