Basic Guide to Writing Effective Pharmacovigilance Standard Operating Procedures (SOPs)

Pharmacovigilance Standard Operating Procedures (SOPs) are the foundation of every reliable PV system. Well-written SOPs are the backbone of your pharmacovigilance (PV) system: they encode legal obligations into daily practice, reduce variability, protect data integrity, and demonstrate control during inspections. They transform global regulatory requirements into clear, actionable workflows that ensure patient safety, regulatory compliance, and operational efficiency.

With evolving expectations from agencies such as the EMA, FDA, and CDSCO, writing effective PV SOPs has become a strategic priority for Marketing Authorization Holders (MAHs), Qualified Persons for Pharmacovigilance (QPPVs), and Pharmacovigilance Officers-in-Charge (PvOIs). This guide highlights the essential components of inspection-ready pharmacovigilance SOPs and provides practical steps to keep them current.

Importance of Pharmacovigilance SOPs

Pharmacovigilance SOPs ensure consistency, traceability, and compliance in safety reporting. Regulatory bodies require that all pharmacovigilance processes such as adverse event reporting, signal detection, and aggregate safety submissions—are documented and executed in a controlled manner.

EMA Good Pharmacovigilance Practices (GVP): In the EU, Good Pharmacovigilance Practices (GVP) explicitly require a documented, controlled PV system, including procedures covering case management, signal management, risk minimisation, periodic reporting, literature monitoring, training, quality management, and audits.

FDA (21 CFR 314.80/600.80): In the US, 21 CFR 314.80/600.80 and related electronic-submission rules require timely expedited and periodic reporting and mandate electronic formats to FAERS; SOPs operationalise these requirements.

India PvPI Guidance (2024): In India, the National Coordination Centre–PvPI and CDSCO provide a PV Guidance Document for MAHs (updated Version 2.0 in 2024) that sets expectations around PvOI responsibilities, case processing, PSMF/PvMF, inspections, and training, your SOP suite must reflect these.

Well-structured SOPs are a key indicator of system reliability during inspections.

Core SOPs Every PV System Must Have

To ensure full coverage of regulatory and safety requirements, a PV system should include SOPs for:

ICSR Case Management – Intake, triage, MedDRA/WHODrug coding, narrative writing, follow-ups, and regulatory reporting timelines.
Electronic Safety Reporting (E2B R3) – Case validation, submission to FAERS/EudraVigilance, acknowledgment handling, and error corrections.
Signal Management – Detection, validation, prioritisation, assessment, and decision-making aligned with GVP Module IX.
Aggregate Safety Reporting – Preparation and submission of PBRERs/PSURs under ICH E2C(R2).
Risk Management Plans (RMPs) – Development and lifecycle management of risk minimisation strategies.
Literature Monitoring – Weekly database searches, review, and case creation procedures.
Pharmacovigilance Agreements (PVAs) – Partner responsibilities, reconciliation timelines, and safety data exchange.
PV Quality Management – Training, deviation handling, CAPA, audits, and inspection management.
PSMF / PvMF Maintenance – Compilation, updates, and readiness for inspection.
Data Privacy and Integrity – GDPR compliance, ALCOA+ principles, and personal data masking in case narratives.

Structure of Effective Pharmacovigilance SOPs

A well-written SOP should follow a consistent structure across the pharmacovigilance system:

Title and Purpose – Clearly linked to regulatory requirements.
Scope – Defined processes, systems, and countries covered.
Roles and Responsibilities – Detailed RACI assignments for QPPV, PvOI, case processors, and reviewers.
Process Flow – Step-by-step workflow with timelines, decision points, and system references.
Data Standards – E2B(R3) fields, MedDRA/WHODrug versioning, and controlled terminology.
Quality Controls – Mandatory QC steps, reconciliation, and documentation standards.
Record Management – Retention rules, archiving, and audit trails.
Annexes – Checklists, templates, flowcharts, and case-handling forms.

This standardised format ensures clarity and enables inspectors to easily follow compliance pathways.

Timelines to Include in SOPs

Regulatory reporting timelines are critical for compliance. SOPs should explicitly mention:

US FDA: 15 calendar days for serious and unexpected adverse events; follow-up submissions within 15 days.
EU EMA: 15 calendar days for serious ICSRs; 90 days for non-serious ICSRs.
India PvPI: Local reporting requirements aligned to CDSCO guidelines.

Including a timeline table in SOP annexes enhances operational clarity.

Best Practices for Modern Pharmacovigilance SOPs

To meet global expectations, SOPs should:

Define “Day 0” for each source of safety data.
Integrate data privacy and de-identification requirements for narratives and attachments.
Document literature monitoring methods, including zero-result searches.
Include AI/automation governance where machine learning tools are used.
Maintain regional annexes to address country-specific requirements without altering the core SOP.

Quality Metrics to Monitor

Effective SOPs define performance indicators that demonstrate control:

Timely expedited reporting (≥98% compliance).
Low E2B(R3) rejection rates.
Narrative completeness and MedDRA coding accuracy.
Signal management cycle times from detection to decision.
On-time aggregate report submissions.
CAPA effectiveness reviews.

Tracking these metrics supports proactive compliance and continuous improvement.

Maintaining Up-to-Date SOPs

Regulators expect SOPs to reflect the most current guidance. Organizations should:

Conduct quarterly regulatory intelligence reviews for EMA, FDA, ICH, and PvPI updates.
Apply version control with clear major and minor revision tracking.
Run mock inspections to validate operational alignment.

Continuous maintenance ensures SOPs remain aligned with global expectations.

Conclusion

Pharmacovigilance SOPs are the operational backbone of safety compliance. They establish clarity, consistency, and accountability in every process, from case intake to aggregate reporting. By embedding regulatory timelines, masking requirements, data standards, and quality controls into SOPs, organizations can build a pharmacovigilance system that is both inspection-ready and patient-centric.

How DDReg Can Help

DDReg partners with pharma and biotech companies to build inspection-ready pharmacovigilance SOPs. From drafting and gap analysis to regulatory intelligence updates, quality system integration, and global PV operations, we ensure your SOPs are compliant, practical, and globally aligned.