,Pharmacovigilance (PV) Audit Services - Overview
Across the product lifecycle, adherence to global regulations, guidelines, and internal processes is critical. Freyr’s Pharmacovigilance (PV) Audit Services verify the appropriateness, implementation, and effectiveness of your PV system. Our experts design audit plans, review findings, and provide detailed recommendations to ensure your organization is inspection ready.
Our approach follows a risk-based model, focusing on areas with the highest impact on patient safety. We cover all types of PV audits — strategic, tactical, and operational — and help your teams prepare for PV inspections conducted by health authorities.
Structure of PV Audits and Training
- Strategic-level audits: Long-term PV audit strategy, approved by senior management.
- Tactical audits: Audit programs defining scope, objectives, and timelines.
- Operational audits: Risk-based sampling, findings, and graded recommendations.
In addition, Freyr’s Pharmacovigilance Audit & Training programs cover refresher, onboarding, and advanced PV training, equipping your team to maintain compliance consistently. Our experienced GVP Auditor and PV Auditor ensure thorough evaluation, aligning with ICH guidelines, GVP modules, and FDA reporting requirements.
Good Clinical Practice (GCP) and Good Pharmacovigilance Practice Auditor (GVP Auditor)
- ICH-harmonized Tripartite Guideline: Guideline for Good Clinical Practice - E6.
- E2B(R3) Individual Case Safety Report (ICSR) Specification and related files.
- E2C(R2) Periodic Benefit-risk Evaluation Report (PBRER).
- Other applicable ICH Guidelines.
- Guidelines on GVP Modules.
- US FDA’s Safety-reporting requirements for INDs and BA/BE studies.
- Post-marketing Safety-reporting for Human Drugs and Biological Products, Including Vaccines.
- US FDA’s Regional Implementation Specifications for ICH E2B(R3) Reporting to the Adverse Event Reporting System (FAERS).
- Providing Submissions in the Electronic Format – Post-market, non-expedited ICSRs, and Technical Questions and Answers.
- E2E Pharmacovigilance Planning.
Why Choose Freyr for PV Audit & Training
- Comprehensive PV audit strategy and documentation support
- Expert review by qualified auditors with global PV compliance experience
- Tailored PV training modules to close gaps and enhance inspection-readiness
- Guidance on regulatory expectations and post-audit follow-up actions
Freyr’s Pharmacovigilance (PV) Audit Services combine audit expertise and targeted training, empowering organizations to maintain compliance, reduce regulatory risk, and safeguard patient safety.
Pharmacovigilance (PV) Audit Services
- Qualified experts with domain knowledge and 40k+ hours spent for audits
- Experts with 20+ years of experience in auditing Service
- Global presence to support local languages for audits
- Certified lead auditors with GPV expertise
- Ready-to-deploy audit assets – templates, checklist, framework
- Right expertise for global quality management for clients
- Enabling clients to achieve minimum findings for external agency audit outcomes
- Quality management processes for ensuring high-quality deliverables
- Local language coverage
- Flexible operating models – remote/onsite
