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PHARMACOVIGILANCE

At Clinexel, Pharmacovigilance team provides various services including Case Processing, Regulatory Submissions, Aggregate Reports, Literature Monitoring, Signal Detection and Risk Management Plans (RMPs). We conduct GVP audits and provide QPPV services in several countries.

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PHARMACOVIGILANCE OPERATIONS (End to End Pharmacovigilance Operations)

PHARMACOVIGILANCE SYSTEMS MASTER FILE (PSMF)

  • Preparation, Authoring and Maintenance of PSMF
  • The PSMF describes the MAH’s PV system and documents the compliance with the legal requirements in the EU/EEA
  • A PSMF must be kept fully up to date at all times. PSMF to be available within 7 days on-request for any National CA to inspect, that is why the day-to-day management, continuous updates, and expertise with handling PSMFs, is one of most critical aspects for all PV systems

QPPV SERVICES

  • EU-QPPV/ QPPV Services
  • Local Safety Officer (LSO) Services for India, EU, CIS Countries, MENA and LATAM
  • Point of contact for Local Competent Authorities
  • Local Regulatory Intelligence
  • Local Literature Monitoring
  • Local Case Processing, Regulatory Submissions & Follow-up.
  • Key Performance Indicators (KPIs)/ Compliance Monitoring

ICSR PROCESSING

  • End to End Management of Case Processing
  • All Activities Starting from Case Triage, Data Entry, Quality Control, Coding, Medical Review, Reportability Assessment, Regulatory Submission, and Follow-Up
  • Review of All Cases by Experienced Pharmacovigilance Physicians
  • Ensuring Compliance Better than Industry Standards
  • High-Quality Narrative Writing
  • 100% QC check

LITERATURE MONITORING

  • Weekly/ Ongoing Literature Searching
  • Identification, Triage & Processing of Literature Individual Case Safety Reports (ICSRs)
  • Integration with Case Processing and 100% Reconciliation
  • PSUR Relevant Literature Search and Evaluation

AGGREGATE REPORTS

  • Complete Authoring and Production as per the Required Format of PBRERs/ PADERs/ PSURs/ DSURs/ASRs/ SBRs/ Addendums
  • Calendar Management and Planning of Aggregate Reports
  • Compliance Monitoring

SIGNAL DETECTION & ANALYSIS

  • Identification and prioritization of Signals
  • Signal Evaluation through Individual Case Safety Reports (ICSRs) & Aggregate Reports
  • Regular Medical Monitoring of Safety Signals
  • Complete Process of Signals including Signal Contextualization, Signal Evaluation, Literature Review for Epidemiological Inputs and Closing of Signal
  • Preparation of Signal Assessment Reports

RISK MANAGEMENT PLANS

  • Complete Authoring and Production of Risk Management Plans
  • Designing of Risk Minimization Measures (RMMs), including Websites, Educational Materials, Medication Guides etc
  • Effectiveness Analysis for RMMs with the help of Surveys and Testing

SAFETY DATA EXCHANGE AGREEMENTS (SDEAs)

  • Preparation of SDEAs Customized per Country Specific Regulatory Requirements.
  • Review of SDEAs
  • Set Up/ Fine Tune Processes to Ensure Compliance with SDEAs
  • Reconciliations with SDEA Partners

QUALITY & COMPLIANCE

  • Review and Manage Compliance Metrics for Key PV Activities
  • Develop and Implement Quality Management System (QMS), including Preparation/ Review of SOPs and Work Practices
  • Closure of Inspection Findings: Identify and Prioritize Improvements & CAPA Support
  • Gap Analysis
  • Good Pharmacovigilance Practices (GVP) Audits: Internal Audits, Self-Inspections, Vendor Audits, Partner Audits

EXPERT SAFETY WRITING SERVICES

  • Preparing Responses to Request for Information (RFI) from Competent Authorities
  • High Quality Narrative Writing
  • Preparing Direct Healthcare Professional (DHCP) Communications
  • Analysis of Similar Events (AoSEs)
  • Benefit Risk Assessment Reports
  • Integrated Safety Summary (ISS)
  • Safety Sections of Clinical Trial Reports
  • Clinical Overview and Clinical Summary

CLINEXEL is a professionally managed Company, a CRO is led by experts with experience in leadership positions in pharma and biotech companies.

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