Local Qualified Professional for Pharmacovigilance (LQPPV) Services

End-to-end Local QPPV services for pharmaceutical and biotech companies. Helping maintain compliant safety operations and effective health authority engagement.

Services We Offer

Local safety operations management as Deputy QPPV for global pharmaceutical and biotech companies

Pharmacovigilance in international markets is critical for global pharmaceutical and biotech product manufacturers to ensure products remain safe for patients while maintaining compliance with local regulations. Health authorities worldwide require a local pharmacovigilance contact, a qualified professional responsible for monitoring and reporting safety concerns, as well as submitting periodic safety reports to authorities.

In addition, the local QPPV is responsible for managing communications with health authorities and participating in safety audits, when required, in close coordination with the global PV team and QPPV. Our LQPPV services include the following:

Artixio’s Local QP Pharmacovigilance Services:

Local Qualified Person for Pharmacovigilance (Local QPPV) Setup

Set up project objectives, budget, scope, and completion of contracts and SDEA
Kick-off meetings
Coordinate review and sign-off of LQPPV qualifications and responsibilities
Preparation of LQPPV and Deputy QPPV nomination documentation
Nomination of LQPPV and Deputy QPPV to the NCA, as required by local regulations
Set up and provide access to all project-specific and general safety mailboxes, as required
Set up project-specific regulatory trackers
Set up ICSR trackers

Local Qualified Person for Pharmacovigilance (Local QPPV) Services

Act as a local contact point for health authorities and as the Qualified Person for Pharmacovigilance (QPPV) or Deputy QPPV
Handle local health authority requests and submit safety notifications (significant safety issues) to authorities
Send monthly reports and maintain ongoing documentation and reconciliation of LQPPV activities
Provide 24/7 availability, including backup personnel, where required by local legislation
Competent authority website monitoring and PV-related regulatory intelligence

Local QPPV Activities

ADR collection and reporting, including but not limited to document collection and translation
Handling local ICSRs (receipt, tracking, and forwarding to MAH/business partners)
Requesting follow-up information from reporters (ICSR follow-up)
Handling other inquiries (MI, PQC, etc.)
Submission of documents to local health authorities
Translation of documents
Attending conference calls, training sessions, and monthly meetings
Participating in audits or inspections and CAPA management
Conducting medical inquiry management
Submitting and managing local PBRERs, PSMFs, RMPs, and local RMP annexes
Training on global SOPs
Tracking and delivery of pharmacovigilance training to local partners
Additional pharmacovigilance support activities, as required
Setup, review, update, and implementation of SOPs
Setup, review, and development of PV agreements
Perform local and global literature screening
Handle product quality complaints with or without adverse events
Daily monitoring of safety mailboxes
Development, update, and submission of PSMFs

Seamlessly Augment Global Pharmacovigilance through Artixio’s Local Pharmacovigilance Services and LQPPV Support

Our 100+ pharmacovigilance experts, based locally across 70+ key global markets, support ongoing safety monitoring and reporting to ensure product safety and compliance with local regulations. Coupled with AI-enabled regulatory intelligence and monitoring, Artixio helps both local and global PV teams stay up to date with the latest local pharmacovigilance regulations and compliance requirements.

Leverage Artixio’s Glocal Expertise with Seamless Global Delivery

Successful Case Studies Local Qualified Professional for Pharmacovigilance Services supporting global clients
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expertise in 70+ markets with 15-35 years of experience
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
Intelligence driven, global pharmacoviglance services supported by regulatory intelligence platform, QuriousRI
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Safety functions

Local Safety Compliance Delivered

Driven by regional regulatory insights related to safety, Artixio enables patient safety through proactive local pharmacovigilance strategies.

Centralized Regulatory Intelligence for Pharmacoviglance Regulations

A centralized, AI-enabled platform for monitoring pharmacovigilance-related regulatory updates from health authorities worldwide.

Commitment to Excellence

With proven experience in successfully managing pharmacovigilance processes and insights gained across different markets, product categories, and therapeutic areas, Artixio is committed to excellence through the implementation of best practices and efficient, reliable solutions tailored to customers’ pharmacovigilance needs.

FAQs

What are the key responsibilities of local qualified professional for pharmacovigilance (LQPPV)?

An LQPPV acts as a local safety officer and deputy to the QPPV from the global pharmacovigilance team to establish and manage local PV functions in line with regional safety regulations. The LQPPV ensures 24×7 availability to record safety incidents and report them to the global PV team.

The LQPPV also acts as a local contact person for health authorities, handling authority requests and submitting safety notifications. In addition, the LQPPV supports activities such as handling inquiries, managing local ICSRs, ADR collection and reporting, coordinating with local distributors, providing training on safety SOPs to local teams, and submitting and managing local PBRERs, PSMFs, RMPs, and related documents.

How do you support local pharmacovigilance across multiple countries?

Artixio is among the leading providers of regulatory and safety services in emerging markets such as APAC and other global regions. With over two decades of regional experience and a strong network of pharmacovigilance professionals, Artixio has built a platform to deliver on-demand safety and regulatory services to global clients.

We have an in-house team of safety professionals and an extended network of locally based affiliates experienced in managing local safety operations for leading global brands. Our team capabilities, combined with an AI-enabled regulatory intelligence platform, help teams stay updated with the latest pharmacovigilance regulations. We support both project-based and staffing models through fractional or full-time contract-based local PV experts on monthly or annual engagements.

What challenges do companies face in managing local pharmacovigilance and how do you address them?

Finding qualified resources with experience in managing local PV activities
Identifying bilingual PV experts proficient in both English and local languages
Lack of clarity regarding local PV regulations
Limited understanding of local health authority audit processes for PV systems and procedures
Limited availability of fractional or part-time PV professionals, as most experts are available only for full-time roles
Lack of access to a vetted network and pool of qualified professionals
Limited visibility into the latest local PV regulations and compliance updates

How do you stay updated with global regulatory changes related to pharmacovigilance?

Artixio uses its internal regulatory intelligence platform, QuriousRI, to track global regulatory changes related to pharmacovigilance. The platform includes:

Current regulations, directives, regulatory insights
Tracking of new regulations, guidelines, and notifications from health authorities worldwide related to pharmacovigilance, post-market surveillance, and product safety
Insights from Artixio’s regional regulatory experts based on industry experience and participation in conferences, seminars, trade shows, and health authority-organized training programs and events
Artixio’s expert opinions and Case Studies
Key insights derived from Artixio’s project experience, reports, and responses to regulatory queries