What are Pharmacovigilance Training Services?
Our services provide tailored training on GVP, ICH E2E, MAH PV systems, and custom workflows, enhancing team competence and ensuring global regulatory compliance for pharmacovigilance operations.
Pharmacovigilance Training for Global Compliance
Empower Your Team with Tailored PV Expertise
At Indivirtus Healthcare Services Pvt. Ltd., our Pharmacovigilance (PV) Training services deliver specialized programs for pharmaceutical companies and MAHs. From GVP and ICH E2E training to custom PV process design, we ensure regulatory compliance and operational efficiency through expert-led, tailored solutions.
Why is it Critical?
Comprehensive PV training ensures team readiness, regulatory compliance, and efficient safety monitoring, supporting audit readiness and robust pharmacovigilance systems.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led PV training, empowering teams with the knowledge and tools to maintain compliance and operational excellence.
Our Expert Training Approach
At Indivirtus Healthcare Services, our Pharmacovigilance Training services are led by certified PV experts specializing in global regulatory standards. We offer foundational and advanced training modules on GVP and ICH E2E, PV system setup for MAHs, and train-the-trainer workshops, alongside custom SOPs and workflows tailored to your organization.
Our approach combines regulatory expertise with practical applications, delivering comprehensive and compliant training solutions that align with global best practices and enhance team competence.
Pharmacovigilance Training Deliverables
GVP & ICH E2E Training Modules: Comprehensive sessions on global PV standards.
PV System Setup Templates for MAHs: Tools for establishing compliant PV systems.
Trainer Kits and Facilitator Guides: Resources for internal training scalability.
Custom PV Process SOPs and Workflows: Tailored procedures for operational efficiency.
Regulatory Compliance & Global Standards
Our Pharmacovigilance Training services align with stringent global standards, ensuring your team is equipped for audit-ready compliance across international markets. By adhering to industry-leading guidelines, we deliver training that enhances regulatory confidence and safety.
- ICH E2E: Guidelines for pharmacovigilance planning and safety management.
- EMA GVP Modules I–XV: European standards for pharmacovigilance operations.
- 21 CFR Part 314: U.S. regulations for post-marketing drug safety reporting.
- WHO Pharmacovigilance Guidelines: Global standards for adverse event monitoring.
Applications & Use Cases
Our Pharmacovigilance Training services are essential for pharmaceutical companies and MAHs seeking to ensure team compliance and efficiency. Ideal for onboarding, system setup, or process optimization, our solutions support global pharmacovigilance requirements. Key use cases include training teams for new drug launches, aligning MAH systems with GVP, and designing custom PV workflows.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies and MAHs, delivering expert-led PV training solutions backed by certified pharmacovigilance experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your team with compliant, effective, and tailored training, driving regulatory success and pharmacovigilance excellence.
Frequently Asked Questions
Frequently Asked Questions
What is covered under GVP and ICH E2E training?
The training covers EMA's Good Pharmacovigilance Practices (GVP Modules I–XV) and ICH E2E guidelines, including signal detection, PSURs, and QPPV responsibilities.
Is this training suitable for MAHs setting up their first PV system?
Yes, we provide system-level implementation guidance, SOPs, and compliance checklists specifically tailored for Marketing Authorization Holders (MAHs).
What is included in train-the-trainer workshops?
These workshops include facilitator handbooks, slide decks, learner assessments, and group activities to enable your internal team to deliver PV training independently.
Can you design PV training specific to our company's processes?
Absolutely. We offer custom PV process design including SOPs, flowcharts, and templates that align with your organization’s specific risk profile and regulatory needs.
Are training sessions available virtually?
Yes, all our training modules are available in virtual, on-site, and hybrid formats based on your preference and team location.
What do Pharmacovigilance Training services include?
Our services include GVP and ICH E2E training modules, PV system setup templates, trainer kits, and custom SOPs/workflows tailored for pharmaceutical companies and MAHs.
Who benefits from Pharmacovigilance Training services?
Pharmaceutical companies, MAHs, and regulatory professionals seeking compliant PV training or custom process design benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with ICH E2E, EMA GVP Modules I–XV, 21 CFR Part 314, and WHO Pharmacovigilance Guidelines, ensuring global regulatory compliance.
What deliverables are provided with the service?
Clients receive GVP/ICH E2E training modules, PV system setup templates, trainer kits, and custom PV process SOPs and workflows.
Can the training services be customized for our needs?
Yes, our services are tailored to your organization’s specific PV needs, regulatory requirements, and operational goals, ensuring effective and compliant training.
How do the services support MAH PV system setup?
We provide templates, SOPs, and training to establish compliant MAH PV systems, aligning with GVP and global pharmacovigilance standards.