IMPLEMENTATION OF COMPANY’S PHARMACOVIGILANCE SYSTEM

• Qualified Person for Pharmacovigilance (QPPV) / Pharmacovigilance Officer In-charge (PvOI).
• Electronic submission of Article 57(2) data
• Creation and review of Pharmacovigilance System Master File (PSMF/PvMF)
• Quality Management System (QMS) in Pharmacovigilance
• Writing and review of comprehensive list of PV Standard Operating Procedures (SOPs)
• Consultancy services concerning working practices and legislation on drug safety
• Tailor-made Training to suit customer needs in Pharmacovigilance
• Pharmacovigilance Processes & Systems Audits
• Support on Health authorities inspections and third party PV audit.
• Write, review and maintenance of Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA)

COLLECTION, PROCESSING AND Aggregate Safety EVALUATION OF ADVERSE EVENTS

• Continuous monitoring of published International and Local Literature and EMA MLM services
• End to end processing (data entry, narrative writing, event coding, medical review, submission) of various types of Individual Case Safety Reports (ICSRs)
• Maintenance of Global Safety Database for processing of ICSR and other activities
• Safety Voice Processing Center (call centre for drug safety)
• Electronic reporting of ICSRs to EMA, FDA and different competent Authorities
• Preparation and submission of Aggregate Safety Reports (PSURs/PBRERs/DSURs)
• Responses to Health Authorities (HA) request on ICSR/expedite reporting, PSUR/PBRER and other safety documents

RISK MANAGEMENT SYSTEM

• Continues monitor of Signal to maintain the Benefit-Risk profile of products with appropriate Signal management
• Preparation of Signal Detection, Signal Validation, Signal Evaluation documents
• Preparation and submission of Risk Management Plan (RMP)/ Risk Evaluation and Mitigation Strategies (REMS)
• Preparation, translation and submission of Dear Health Care Professional Letters (DHPC)
• Preparation and update of Reference Safety Documents (CCSI/SmPC/CDS)

Monitor, submission, respond to Health Authorities (HA) request for the assessment of Benefit-Risk profile of the products.