• OBJECTIVE:

To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GMP, and local regulatory requirements.

• SCOPE:

This SOP applies to all PV activities in the organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and oversight of PV partners.

• RESPONSIBILITIES:
  • Qualified Purson for Pharmacovigilance (QPPV):
    • Ensure continuous and overall oversight of the company’s PV system.
    • Be permanently and continuously available (directly or via delegation during absence).
    • Ensure the safety profile of all company products is monitored.
    • Review, approve, and oversee:
      • Individual Case Safety Reports (ICSRs)
      • Periodic Safety Update Report (PSUR)
      • Periodic Benefit-Risk Evaluation Report (PBRER)
      • Business Continuity Plan (BCP)
      • Signals and risk minimization measures
    • Ensure timely submission of ICSRs, PSURs, RMPs, signals, and regulatory notifications.
    • Maintain the Pharmacovigilance system master file (PSMF) and ensure accuracy of its content.
    • Ensure PV training is provided to all employees (training management follows QMS training SOP).
    • Ensure safety agreements (SDEA) are in place with external partners and are properly implemented.
    • Oversee safety-related quality issues and deviations.
    • Participate in audits and regulatory inspections.
    • Ensure systems are in place for signal detection, risk communication, and crisis handling.
    • Act as the primary contact for regulatory authorities on PV matters.
    • Ensure backup QPPV or deputy is nominated, trained, and competent.
    • Provide medical assessment when required.
• Backup QPPV:
  • Act in place of QPPV during absence.
  • Follow same responsibilities within delegated scope.

 Head PV:

• • Manage day-to-day PV activities.
  • Ensure AE collection and documentation.
  • Coordinate with RA, QA, production, medical, and external partners.
  • Maintain PV logs (ICSR, signal, literature).
  • Provide inputs for PSURs and PSMF.
  • Coordinate safety-related communications.

 Regulatory Affairs (RA):

• • Ensure country-wise reporting timelines are updated and available.
  • Submit PSURs, RMPs, and safety notifications to authorities.

 Quality Assurance (QA):

• • Manage deviations, CAPA, change control as per QMS.
  • Ensure PV requirements are included during supplier qualification and contracts.
  • Ensure PV documents are archived as per QMS.
• Production / Warehouse / Field Staff
  • Report any Adverse Event (AE), complaint, or product issue immediately to PV.

DEFINATIONS:

• Pharmacovigilance (PV) System: A Pharmacovigilance System is a comprehensive, legally required organizational framework established by a marketing authorization holder (MAH) to ensure ongoing monitoring of the safety of its medicinal products.
• Qualified Person for Pharmacovigilance (QPPV): A QPPV is a legally designated, highly qualified individual responsible for the overall safety oversight of the company’s medicinal products marketed in a country or region.
•  Pharmacovigilance System Master File (PSMF): A Pharmacovigilance System Master File (PSMF) is a comprehensive, detailed, and continuously updated document that describes the entire PV system of the marketing authorisation holder.
• Individual Case Safety Report (ICSR): An Individual Case Safety Report (ICSR) is a structured, complete, and validated report of a suspected adverse drug reaction (ADR) observed in a patient.

PROCEDURE:

PV System Establishment:

Establish a structured PV department with defined roles.

Ensure QPPV and deputy are appointed and documented via organizational chart.

Maintain PSMF describing the PV system, sites, responsibilities, procedures, and contracts.

Review and update PV SOPs periodically.

Maintain validated safety databases for case management.

 Oversight of PV Activities:

• QPPV performs periodic reviews of:
  • • Case reporting compliance
    • Literature screening compliance
    • Signal detection activities
    • PSUR/RMP preparation status
• QPPV conducts monthly PV review meetings with documented minutes.
• Escalate significant safety findings to top management immediately.

Interaction with Cross-functional Units:

• QPPV or PV manager communicates with QA for quality-linked safety issues.
•  Regulatory Affairs (RA) provides regulatory updates to PV.
•  All departments route AE/PQC information immediately to PV.

 Safety Agreements (SDEA) Oversight:

• QPPV ensures all partners (CRO, distributor, CMOs) have signed SDEA.
•  QPPV periodically reviews compliance of partners.

 Regulatory Communication:

• QPPV ensures accurate and timely reporting of all ICSRs.
• QPPV acts as regulatory contact for urgent safety matters.
• Safety communications (DHCPL, field safety notices, recalls) are reviewed and approved by QPPV.

 PV Documentation Management:

• All PV documents are controlled as per QMS document control SOP.
• Maintain PV logs and registers.
• Archive safety data securely and retrieval-ready.

 Training:

• All employees shall undergo initial and periodic PV training.
• Training records shall be maintained as per QMS training SOP.

 Deviation and CAPA:

• Deviations related to PV activities shall follow Quality Management System (QMS) deviation & CAPA SOP.
•  QPPV must review PV-related deviations.

 Records:

• The records below shall maintain:
• • • Appointment letters of QPPV and backup
    • Job Responsibilities QPPV and Back up QPPV
    • Organizational chart
    • PSMF
    • PV logs (ICSR, literature, signals)
    • Review meeting minutes
    • Safety Data Exchange Agreements (SDEA)
    • Training records

 REFERENCES:

• WHO Technical Report Series (TRS) – PV guidance
•  EU Good Pharmacovigilance Practices (GVP)
•  Company QMS SOPs (Document Control, Training, Audit, Risk Management, Deviation & CAPA)

RECORDS:

REVISION HISTORY.