• Set up and implementation of Pharmacovigilance System
• Development and maintenance of Pharmacovigilance System Master File (PSMF)
• 24/7 availability as of Qualified Person for Pharmacovigilance (QPPV) and Local contact person for Pharmacovigilance (Local QPPV)
• International and Local Literature Review
• Regulatory Intelligence Services
• Authority Website Monitoring
• Product Complaints Management & Reporting
• Adverse Events case Processing & Reporting
• Signal detection and Management
• Aggregate reports (PSUR/ PBRER/ PADERs)
• Preparation/maintenance of Risk Management System (RMS), Risk Management Plan (RMP) and Risk Minimisation Activities
• Direct Healthcare Professional Communication (DHPC) management
• Safety Data Exchange Agreements (SDEA) preparation and maintenance
• Training
• Supporting of Expertise process of PV System by NCA
• Audit and inspection readiness

• Appointment of Local Contact Person for Food Supplement Vigilance
• Comprehensive management of adverse events of food supplements reported by consumers, health professionals or authorities
• Submission of serious adverse reactions to the manufacturer
• Periodic search of safety information of food supplement products in scientific literature
• Food supplement Product Safety Report
• Signal Detection and Management

• Appointment of Local Contact Person for Cosmetovigilance
• Comprehensive management of adverse events of cosmetic reported by consumers, health professionals or authorities
• Submission of serious adverse reactions to the manufacturer
Periodic literature search in scientific literature to identify safety information and adverse events of cosmetic products
• Cosmetic Product Safety Report
• Signal Detection and Management

Under development

• Collection, investigation, and assessment of Adverse Device Effects (ADE) / Medical Device Incidents (MDI)
• Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to manufacturer
• Monthly compliance and status reporting
• ADE and MDI Reconciliation
• Preparation of Periodic Summary Reporting
• Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
• Writing and/or reviewing Standard Operating Procedures
• Periodic literature search in scientific literature to identify safety information and adverse reactions of food supplement products

• Individual Case Safety Report (ICSR) Processing (Medical Evaluation of Cases)
• Safety Database
• Serious Adverse Event (SAE) Reconciliation (Necessary for Regulatory Authorities (RA) Submission)
• Serious Adverse Event (SAE) Narratives Preparation
• Case Report Form (CRF) and line-listings safety review (To address any site concerns regarding health state of participants)

• Study Abstracts
• Clinical Protocols
• Informed Consent Forms
• Patient Information Sheets
• Case Report Form
• Clinical Study Reports
• Risk Management Plan /Risk Evaluation and Mitigation Strategy (RMP/REMS)

• MedDRA Terms Coding (using the latest version of MedDRA dictionary)
• WHO Drug Terms Coding
• Coding Consistency Review (in accordance with MedDRA, WHO Drug and other specific recommendations)