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-GVP, 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 authorization 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.