Highlights:

Skills:Compliance Case Processing, MedDRA, ICSR, Drug Safety Monitoring, Pharmacovigilance (PV), Adverse Event Reporting (AER), EudraVigilance Compliance, MedDRA (Medical Dictionary for Regulatory Activiti, Adverse Event Reporting (AER)

Pharmacovigilance Specialist Pharmacovigilance (PV) Adverse Event Reporting (AER) Safety Signal Detection Case Processing and Medical Review ICH Guidelines (International Council for Harmonisation) EudraVigilance Compliance MedDRA (Medical Dictionary for Regulatory Activities) Qualified Person for Pharmacovigilance (QPPV) Risk Management Plans (RMP) Drug Safety Monitoring Pharmaceutical Industry CRO (Contract Research Organization) Clinical Research Regulatory Submissions Global Health Regulations Training and Mentorship Team Leadership Cross-functional Collaboration Project Management Root Cause Analysis Quality Review and Compliance Check Team Training and Development Stakeholder Engagement Process Improvement FDA Regulations (Food and Drug Administration) GVP (Good Pharmacovigilance Practices) Quality Assurance (QA) Regulatory Compliance CAPA (Corrective and Preventive Action) Global Regulatory Affairs Standard Operating Procedures (SOPs) Good Documentation Practices Safety Data Reporting Audit Preparation and Support